← Regulatory Affairs & Quality Management

Quality Assurance Services

At Veranex, we understand that Quality Assurance is not a one-size-fits-all solution. That is why we provide full-service quality consulting services to support the development, implementation, and maintenance of right-sized, stage-appropriate Quality Management Systems (QMS) for our clients.

QMS Implementation and Certification

An efficient QMS must be aligned with your business needs and objectives. Our QMS specialists have the expertise to implement the right tools and processes for your organization, ensuring a pragmatic and adaptable approach to meet your evolving needs.

We offer guidance on eQMS platforms and provide support with implementing and customizing standard operating procedures based on your manufacturing process, device characteristics, suppliers, etc.

QMS Remediation

Dealing with non-conformities can be a stressful experience, but with the right team and processes in place, you can ensure that your QMS is compliant, reducing quality issues and improving your overall business performance.

At Veranex, we provide support in identifying non-conformities, whether they are detected internally by your team, by an auditor, or by our own experts. We then help you implement corrective actions to address these issues, which may involve updating policies and procedures, providing additional training to employees, or implementing new technology or systems.

Due Diligence, Audits, and Inspections

Our teams at Veranex have extensive experience interacting with regulatory authorities and understand the QMS requirements for compliance. We work closely with you to ensure your processes are aligned and audit-ready.

For manufacturers seeking to meet the requirements of authorities from different countries, the MDSAP program harmonizes the medical device evaluation criteria, allowing to achieving a common certification in Australia, Brazil, Canada, USA and Japan.

How does it feel to work with the Veranex Quality Assurance Team?

Our Veranex team strives to implement and maintain a QMS that aligns with your business objectives, ensuring compliance while minimizing unnecessary burden.

We often start with an internal audit to assess your current system and detect any non-conformities. Our specialists then propose updates to your QMS documentation, including a new QMS process map, simplified QMS documents, identification of critical areas, etc.

Our sub-system-based approach ensures Good Manufacturing Practice (GMP) requirements are seamlessly integrated into your daily operations, making your QMS an efficient and effective tool for corporate management.

Our team provides coaching for the implemented changes and additional training as necessary, ensuring a smooth transition.

Quality Assurance Services & Capabilities:

  • QMS Implementation & Certification
    • QMS strategy and implementation
    • Development of flexible QMS documentation, easily adaptable to changes and improvements
    • QMS Gap assessments
    • ISO 13485 certification support
    • Assistance in selection of Notified Body
    • Implementation of IEC 62304 requirements for software development
    • Integration of multiple requirements (MDR, IVDR, ISO 13485, FDA QSR, Japan Ord. 169, Brazil RDC 16/2013) into the scope of the QMS
    • MDSAP
  • QMS Remediation
    • Ongoing QMS maintenance (management and annual product reviews, CAPAs, nonconforming materials, training, suppliers, etc.)
    • Inspection/audit response and remediation support (including FDA 483 observations)
    • On-site training for FDA QSR, ISO 13485, ISO 14971, IEC62304 requirements
  • Due Diligence, Audits and Inspections
    • Audits: ISO 13485, IEC 62304 (software), Quality System Inspection Technique (QSIT), Preapproval Inspection (PAI), Medical Device Single Audit Program (MDSAP), EU MDR, California FDB, supplier, internal, etc.
    • Agency inspection/audit preparation and support: FDA, CA FDB, notified bodies, global (e.g., Canada, China, Japan, Australia, Brazil, Korea, etc.)
    • Inspection/audit response and remediation support
    • Post market support (complaints, medical device reports, field actions/recalls, mandatory problem reporting, vigilance reporting, postmarket surveillance reporting, etc.)