Interactive Guide 1 – 2

by | Jun 7, 2024 | Interactive Guide 1

Establishing Design Project Plan
Establish Product Description / Specifications / Labeling
Risk Management
Establish Validation Plan

Establish Project Team and Responsibilities

Design Control

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.

Design Review

A documented formal approval of the design results associated to a phase of the design process.

Establishing Applicable Standards

Determining what standards are applicable to a particular medical device.

Product Description

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. This document may expand based upon subsequent considerations or based on user/customer needs. The Product Description/Definition should establish the initial intended use and indications for use of the device.

Intended Use

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/Use Cases

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.

Risk Management Plan

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.

Benefit Risk Assessment

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.

Hazard Analysis

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.

Harms List

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.

Design, User, Processes, SW FMEAs, etc.

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.

Product Specification and other design Specifications

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.

Device Master Record (DMR)

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.

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.

V&V (Verification and validation)

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.

Establish Regulatory Plan

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.

Establish checklists for other regulatory requirements (country specific)

Determine if there are any other country-specific requirements (e.g. Canada, MDSAP, MDR, etc.)