VERANEX
DESIGN CONTROL GUIDE
Effectively managing all design control requirements can be a smooth process, if planned and implemented in line with the product, business goals and regulations to avoid challenges for medical device manufacturers.
To assist you with this endeavor, our team has meticulously mapped out key steps of the Design Control process that you can explore below:
1. Development Phase
Interactive Guide 1 – 1
1.1. Design Project Plan
The Design Project Plan identifies and describes the specific plan for the design and development activities to be performed including a proposed timeline with projected milestones. The plan includes proposed quality practices, assessment methodology, record-keeping and documentation requirements, an assessment of resource requirements, an assessment of the acceptable risk/benefit for the specific design and a formal timeline or sequence of events related to the particular design or design category. The plan may also include regulatory strategies for the specified countries and projected market release dates.
Includes defining roles, responsibilities, and accountability for each team member throughout the product lifecycle.
The Design Control Process manages the development and transfer of new medical device products and design changes to existing medical devices for product release to market. The Design Control Process is initiated when technical feasibility of a design/solution has been determined. The Design Control Process applies to the entire device development process from project initiation through to the release of production specification(s) and product release to market.
A documented formal approval of the design results associated to a phase of the design process.
Determining what standards are applicable to a particular medical device.
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1.2. Establish Product Description/Specifications/Labeling
A formal description of the proposed product and design requirements based on customer requirements determined from a variety of sources including customer feedback, formal or informal customer surveys, physician feedback, peer-reviewed literature, and medical meetings, presentations and abstracts, and issues identified with previous versions of the device. The Product Description/Definition should establish the initial intended use and indications for use of the device.
The general purpose of a product, which is the objective intent of the persons legally responsible for labeling of a product (or their representatives).
User Needs and Use Case documents additional inputs to ensure that the requirements for the device to meet its intended use and the needs of the customer, user, and patient have been identified. Input considerations may include performance characteristics, product specifications (including tolerances and precision requirements), product features and benefits, proposed indication(s) for use, product indication(s) and contraindications, safety and reliability requirements, environmental requirements and limitations, accessories, interfacing/use with other devices, device serviceability, labeling, applicable national and/or international standards, and regulatory requirements. User Needs and Use Cases are used as an input into the Product Specification.
Claims are part of marketing and advertising of the product which must be correctly describing the device's intended purpose, safety and performance. Claims must not be misleading and must be within scope of the device’s cleared indications for use.
A specific definition of the labeling requirements for product labels, the instructions for use, and any marketing literature required for the design. An assessment of the compliance of the labeling with applicable regulatory requirements, identification of the costs and lead times for procuring the labeling should be performed. The applicable requirements for Unique Device Identification (UDI) must be established at this stage.
Interactive Guide 1 – 3
1.3. Risk Management
Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk.
The Risk Management Plan establishes the project roadmap for the risk management activities to be conducted during the life cycle of the medical device. The Risk Management Plan must include the criteria for risk acceptability for the medical device being developed.
A preliminary assessment of the acceptable level of risk and benefit associated with the proposed device design. The product risk assessment is intended to outline the acceptable ratio of benefit and feature characteristics as compared to known and potential clinical adverse events.
The Hazard Analysis is a listing of all known and foreseeable hazards. Hazards must include use of the device in both normal and fault conditions. The list should represent a full description of the device and how it is intended to be used. Things to consider include previously recognized hazards associated with similar devices, and the foreseeable sequence(s) of events that may result in a hazardous situation.
A Harms List is a list of potential harms, the definition (including examples) of those harms and the associated severity level of those harms based on the Risk Acceptability Criteria definitions established for the device in the in the Risk Management Plan. This Harms List is important to assure that the descriptions of Harms used throughout the design documentation are constant in meaning (definition) and associated severity of harm with regards to the established Risk Acceptability Criteria in the Risk Management Plan.
Detailed assessments of the risks associated with the device design, risks to the patient and/or user when using the device and any manufacturing process risks for the device. Failure Modes and Effects Analysis (FMEAs) are part of risk analysis.
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Product Specification contains general information about the product, the required performance characteristics, material characteristics, packaging characteristics, the proposed product labeling and any installation/servicing requirements.
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A document that includes or refers to the location of the following information: Device specifications including software specifications, device installation specifications, device maintenance specifications, quality assurance procedures and specifications including acceptance criteria and any quality assurance equipment to be used, labeling specifications, including processes used, maintenance, and servicing procedures and methods.
Interactive Guide 1 – 4
1.4. Validation Master Plan
A macro–level plan that identifies all the activities to be undertaken to assure the device design, equipment and quality system process(es) consistently produce devices that meet the formal design input requirements.
Independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.
Interactive Guide 1 – 5
1.5. Regulatory Compliance
Process of ensuring that a medical device meets all applicable regulations, standards, and guidelines set by regulatory bodies such as the U.S. FDA, European Notified Bodies, etc. These regulations are in place to ensure the safety, efficacy, and quality of medical devices before they reach the market.
A formal plan outlining the recommended strategy for obtaining or verifying regulatory approval to market(s) the proposed product in the designated countries. Depending upon the identified marketing goals, this may include strategies for dealing with the specific requirements of the applicable international regulatory agencies, including applicable national and international regulations and standards.
Determine if there are any other country-specific requirements (e.g. Canada, MDSAP, MDR, etc.)
2. Design Transfer Phase
Interactive Guide 2 – 1
2.1. QMS Processes
Established procedures, policies, and controls that ensure the consistent quality of the medical device throughout its development, manufacturing and post-market.
Process for establishing competence, providing needed training and ensuring personnel awareness to the Quality Management System and work affecting product quality.
Process to provide a means for the controls and related responsibilities and authorities for the identification, documentation, evaluation, disposition and notification of nonconforming product.
Process to verify that the installed system functions according to its design, user requirements, and GAMP (good automated manufacturing practice) requirements.
Process to manage design or process changes which can include corrective actions, changes implemented to solve the original issue, changes to turn features on and off for customers, and changes/updates in design documents.
Process for the creation, control and revision of controlled documents and the associated requirements for review, approval, final release, distribution and archiving.
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Process for how product-related complaints are evaluated, investigated, documented, trended and closed in a consistent and effective manner for commercially released product only.
Note:
Complaint refers to any written, electronic, or oral communication that. alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or. performance of a device after it is released for.
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Process to identify, evaluate, correct and/or remove product from commercial distribution where a potential or verified nonconformance in the product or product processing has occurred.
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Process that describes the responsibilities and requirements for planning and conducting internal audits, documenting and reporting internal audit results.
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Process to allow management, with executive responsibility, to review at defined intervals the continuing suitability, adequacy and effectiveness of the Quality Management System. Management Review is intended to assess any opportunities for improvement and the need for any changes to the Quality Management System, including the Quality Policy and Quality Objectives.
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Process in which product final acceptance is achieved by the completion of: the specified verification and validation activities; product specifications and manufacturing process procedures are finalized and released; all product labeling is finalized and released and meet the appropriate requirements for Unique Device Identification (UDI) or Universal Product Code (UPC); the Device Master Record is released, the record retention requirements for the product have been finalized.
Interactive Guide 2 – 2
2.2. Supplier Management
The process for the evaluation, selection and re-evaluation of suppliers providing completed devices, components, materials, accessory devices, and global cloud services to ensure all the products and services meet the specifications.
Processes and requirements for selecting, evaluating, and monitoring suppliers and subcontractors.
The process of assessing, approving and re-assessing approved suppliers to ensure they continue to meet the established qualification criteria.
Systematic, planned, and documented assessments conducted by the medical device manufacturer (or their representative) to evaluate a supplier's ability to meet the specified requirements.
Procedures used to address any issues or nonconformances identified with a supplier's performance.
Documented record of suppliers that have been evaluated, qualified, and approved by the medical device manufacturer.
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Processes and procedures used to oversee the suppliers that are responsible for distributing or importing the medical device.
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Defining and implementing key performance indicators (KPIs) to measure and monitor the performance of the approved suppliers.
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Evaluation of a supplier's ability to meet the current and future production demands.
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Periodic assessment and review of approved suppliers to ensure they continue to meet the medical device manufacturer's requirements.
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Ongoing activities and systems used to track, evaluate, and maintain oversight of approved suppliers.
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Managing and controlling changes to the approved suppliers or the materials/components they provide.
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Maintenance of the Approval Supplier List (see above).
Interactive Guide 2 – 3
2.3. Environment Control (Manufacturing, Storage)
The controlled conditions, such as temperature, humidity, cleanliness, accessibility and layout, required for the production and storage of the medical device and its components to meet the specified design and quality requirements.
Systematic and controlled movement, storage, and management of materials, components, and products throughout the production process.
Specialized, highly-regulated, and tightly-controlled area or facility designed to minimize the introduction and presence of contaminants.
The storage and management of raw materials, in-process materials, and finished goods are critical components of the overall material handling and quality control processes.
Range of activities to ensure the seamless and compliant distribution of products, including managing the distribution network, optimizing inventory and order fulfillment, maintaining product traceability and recall management, and continuously monitoring and improving the distribution processes.
Critical regulatory requirement requiring device manufacturers to register their facility with regulatory bodies such as the FDA that ensures the manufacturing sites and other related facilities meet the necessary standards for the production, handling, and distribution of medical devices.
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Critical aspect of maintaining regulatory compliance and ensuring the continued quality and safety of medical devices that includes identifying and evaluating proposed changes, conducting risk assessments, implementing a formal change control procedure, validating and qualifying the modifications, training personnel, communicating with stakeholders, and continuously monitoring the changed facility or processes for ongoing compliance and improvement.
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Critical component of business continuity and risk management that includes risk assessment, data and system backup, establishing alternate manufacturing sites, and establishing a comprehensive incident response plan for when an unexpected disaster occurs that could adversely affect the business activities or device development, installation, monitoring or maintenance processes.
Interactive Guide 2 – 4
2.4. Manufacturing Processes
The documented procedures, equipment, and methods used to produce the medical device in a consistent and controlled manner, ensuring the final product meets the design specifications and regulatory requirements.
Crucial tool for medical device companies to understand, document, and optimize their production workflows and procedures.
Process Failure Mode and Effects Analysis is a critical tool to identify and mitigate potential failures within the manufacturing processes.
Process to ensure the reliability, accuracy, and consistency of the testing procedures used to evaluate the performance, safety, and quality of medical devices.
Installation Qualification, Operational Qualification, and Performance Qualification ensure that manufacturing equipment and instrumentation are properly installed, operated, and performing as intended.
Plan that maps out the essential components of a medical device company's QMS, ensuring the reliability and consistency of their manufacturing processes.
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Ensuring that manufacturing processes consistently yield products meeting predetermined quality criteria.
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Defining, monitoring and managing KPIs to ensure consistent product quality and compliance with regulatory standards.
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Systematic checks during production and after completion to verify that the products meet specified quality and safety standards.
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Critical procedures that ensure products are safe, effective and free from contaminants, requiring rigorous validation due to their impact on product quality and patient safety.
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Maintaining detailed and accurate documentation of production activities, ensuring traceability, compliance with regulatory requirements, and the ability to review and verify the manufacturing process and product quality.
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Continuously tracking and analyzing production parameters and performance metrics to ensure processes remain within specified limits.
Process Change Management
Systematically evaluating, approving and documenting any changes to production processes, to ensure that these changes do not adversely affect product quality or safety.
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Implementing and maintaining systems and procedures to ensure that all services related to the product lifecycle consistently meet quality and regulatory standards.
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Identification, design, and implementation of automated processes and systems to improve the efficiency, consistency, and reliability of manufacturing operations.
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Used to systematically monitor, evaluate, and optimize manufacturing processes through the collection and statistical analysis of process data, enabling proactive identification and resolution of potential issues to ensure consistent product quality.
Interactive Guide 2 – 5
2.5. Product Specifications
The product specifications are the formal design inputs and as such must contain the information about the product, material characteristics, packaging characteristics, required functional, performance, reliability, usability, labeling, delivery, safety, and security requirements, and any installation/servicing requirements.
Detailed technical requirements and characteristics for the individual components or parts that make up the final medical device product.
Critical quality control checkpoints to verify that raw materials, components, and initial production units meet all specified requirements before proceeding with manufacturing.
Communication of design changes, nonconformities, quality issues, and regulatory updates.
Device Master Records and Bill of Materials (BOM) Management refer to the comprehensive documentation and control of the product design specifications, components, and manufacturing information.
The proper identification, procurement, and maintenance of safety information for all materials and substances used in the manufacturing of the medical device.
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Key components of the medical device design control process, providing detailed manufacturing procedures and comprehensive production history documentation to maintain quality and traceability.
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The formal review, approval, and documentation of any changes made to the product specifications, ensuring the changes are properly evaluated and implemented to maintain product quality and compliance.
3. Commercial Phase
Interactive Guide 3 – 1
3.1. Process Changes / Facility Changes
Modifications made to manufacturing processes or production facilities to improve efficiency, adapt to new regulations, or address quality issues.
Evaluation of the impact of any changes to the manufacturing process on product quality and compliance.
Verification that the modified manufacturing processes consistently produce a product that meets the pre-determined specifications and requirements.
Oversight and control of suppliers to ensure the continued quality and compliance of purchased materials and components.
First Article Inspections to evaluate the conformance of the initial production unit after a process or facility change.
Assessment of the impact on product quality and compliance when transferring production to a new or modified facility.
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Independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.
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Ensuring that the testing methods used to evaluate product quality and compliance are reliable and suitable.
Interactive Guide 3 – 2
3.2. Production Support
Providing ongoing technical assistance, troubleshooting, and maintenance to ensure smooth and efficient manufacturing operations, while addressing any issues that arise to maintain consistent product quality and regulatory compliance.
Approval and release of each production batch for distribution based on meeting the specified quality and regulatory requirements.
Inspection and testing of raw materials, components, and supplies to verify conformance before use in manufacturing.
Monitoring and testing of the manufacturing process to identify and address any quality issues during production.
Final inspection and testing of the finished medical device to ensure it meets all quality and regulatory specifications before release.
Identification, investigation, and resolution of any product or process deviations from the established requirements.
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Maintaining the accuracy and reliability of the equipment and instruments used in the manufacturing and testing processes.
Interactive Guide 3 – 3
3.3. Vendor Management
The process for the evaluation, selection and re-evaluation of suppliers providing completed devices, components, materials, accessory devices, and global cloud services to ensure all the products and services meet the specifications.
Periodic assessment of suppliers to ensure their continued compliance and ability to meet the medical device manufacturer's requirements.
On-site evaluations of suppliers to verify their manufacturing processes, quality systems, and overall compliance.
Supplier Corrective Action Requests to address any identified nonconformities or issues with supplied materials or components.
Review and approval of any changes proposed by suppliers that may impact products or processes.
Interactive Guide 3 – 4
3.4. Design Changes
Design/process changes include corrective actions, changes implemented to solve the original issue, changes to turn features on and off for customers, and design documents updated to reflect the changed design.
Evaluation of the impact of any proposed design changes on the product's performance, safety, and compliance.
First Article Inspections to verify the conformance of the initial production unit after a design change.
Independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.
Interactive Guide 3 – 5
3.5. Continuous Monitoring
Process of data collection, trending, monitoring, and analysis used for design verification and monitoring of medical devices.
Periodic assessment of the QMS’s performance and effectiveness.
Regular evaluations of the company's processes and procedures to ensure compliance with established policies and regulations.
Ongoing assessment and mitigation of potential risks associated with the medical device throughout its lifecycle.
Identifying and addressing the implications of any changes in applicable standards or regulations.
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3.6. QMS Trending
Trending for data and performance of Quality Management i.e. trending of audit observations, CAPAs and product issues, etc.
Analysis of customer complaints to identify any patterns or recurring issues.
Review of the effectiveness of corrective and preventive actions taken to address identified quality problems.
Monitoring and evaluation of supplier quality, delivery, and responsiveness to maintain a reliable supply chain.
Interactive Guide 3 – 7
3.7. External Assessments
Evaluations conducted by independent organizations or regulatory bodies to verify that the manufacturing processes, quality systems, and product outputs meet established standards and regulatory requirements, ensuring continued compliance and market approval.
Regulatory inspections by the relevant authorities to ensure compliance with applicable regulations.
Assessments by a designated Notified Body to verify compliance with the requirements for CE marking.
Evaluations conducted by customers to assess the medical device manufacturer's quality system and manufacturing capabilities.
Interactive Guide 3 – 8
3.8. Product Maintenance
Overarching process that can include updates and changes, servicing, technical support, etc.
Proper setup and configuration of the medical device at the customer's site to ensure proper functioning.
Maintenance, repair, and support activities conducted on-site or remotely to address any issues with the installed medical device.
Interactive Guide 3 – 9
3.9. Post-Market Surveillance
Process that defines the requirements for the Post-Market Surveillance (PMS) review and evaluation of the medical device’s continued safety and performance to assure that all post-market surveillance-related information is effectively collected, summarized and reported within Quality Management System for medical device products.
Reporting of any adverse events or product issues to the relevant regulatory authorities.
Investigating and addressing any customer complaints or concerns related to the medical device.
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3.10. Marketing/Promotional Materials Processes and Review
Process for the creation, review and approval of the medical device Promotional/Marketing materials including text and format of the materials (i.e. website, social media posts, brochures, etc.) to ensure that the information is truthful and not misleading and will not trigger any compliance issue with regulatory bodies.
Process for the creation, review and approval of the medical device Promotional/Marketing materials including text and format of the materials (i.e. website, social media posts, brochures, etc.).
Ensure that the information is truthful and not misleading and won't trigger any compliance issue with regulatory bodies.
4. On-Going Processes
Interactive Guide 4 – 1
4.1. Document Control and Record Management
Document Control: Process for the creation, control and revision of controlled documents and the associated requirements for review, approval, final release, distribution and archiving.
Control of Records/Records Management: Process that defines the minimum requirements for the identification, storage, security and integrity, retrieval, retention time and disposition of Quality Records necessary to demonstrate compliance with corporate, federal and international requirements and regulations and for effective operation of Quality Management System.
Training for the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner.
eQMS, or electronic Quality Management System, is a software that helps maintain and manage Quality Management System.
Process for identifying gaps in the existing procedures and processes due to changes or updates in external documents such as standards and guidance documents to ensure compliance.
Process for establishing competence, providing needed training and ensuring personnel awareness to the Quality Management System and work affecting product quality.
Interactive Guide 4 – 2
4.2. CAPA (Corrective and Preventive Action)
Corrective Action: Action taken to eliminate the cause of a nonconformity and prevent recurrence. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.
Preventive Action: Action taken to eliminate the cause of a potential nonconformity or other potential undesirable situation.
Process for applying corrective and/or preventive actions, and for subsequently monitoring implemented actions to ensure their suitability, adequacy and effectiveness for the Quality Management Systems and medical device safety and performance.
Process to identify, evaluate, correct and/or remove product from commercial distribution where a potential or verified nonconformance in the product or product processing has occurred.
Process for how product-related complaints are evaluated, investigated, documented, trended and closed in a consistent and effective manner for commercially released product only.
Note:
Complaint refers to any written, electronic, or oral communication that. alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or. performance of a device after it is released for.
Interactive Guide 4 – 3
4.3. Training
Process for establishing competence, providing needed training and ensuring personnel awareness to the Quality Management System and work affecting product quality.