What is regulatory affairs in medical devices?

The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.

What is a medical device traceability matrix?

A traceability matrix is a visual representation of the relationships and linkages between key areas of your design process, for example, your User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation.

What goes into a DHF?

Here are the specific documents that you should include in your DHF:

• User needs and design inputs you defined at the start of the project.
• Design outputs that you generated to build the device.
• Design verification and validation protocols and reports.

What is quality assurance and regulatory affairs?

Regulatory affairs professionals are concerned with ensuring that products comply with government regulations, while quality assurance professionals are focused on delivering high-quality products to consumers.

What are the challenges of medical devices?

Medical Device Manufacturing: Five Challenges in Maintaining Compliance

• Complex Regulatory Requirements. Every medical device manufacturer must follow government regulations or guidelines to sell its product.
• Product Development and Supplier Involvement.
• Process Development.
• Intricate Supplier Issues.
• Cybersecurity.

What are challenges for the design of medical devices?

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

• High Costs of Product Design and Development.
• Regulations and Government.
• Technology and Security.
• Product Quality and High Recall Rates.

Which tool supports validation of the requirements process?

The traceability matrix is a tool both for the validation team, to ensure that requirements are not lost during the validation project, and for auditors, to review the validation documentation.

What is a medical device file?

Medical device files are documents that includes descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, levels of compliance with regulatory bodies and quality standards, and, if required, servicing and installation records and their …

What is design control process?

Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices).