FDA compliance: How to assess a medical device contract manufacturing partner

The FDA continually remind OEMs they are responsible for the end-to-end quality management of their products from development to distribution. How can you ensure your medical device manufacturer is able to meet their rigorous standards?

As American regulatory expert Alan Schwartz of Mdi Consultants points out:

“The FDA expects that the OEM will view the contract manufacturer as an extension of its own operations.”

Ensuring quality in your contract manufacturer

With this in mind, we asked ESCATEC Medical’s Quality Manager, Teng Mei Fong, for her advice on picking a contract manufacturer capable of meeting the quality demands required in the medical device sector:

“At a minimum, your supplier should have gained the medical device QMS standard ISO 13485:2016 and have a track record of meeting regulatory requirements in the regions where you plan to launch.” says Teng Mei Fong.

As America is the largest medical device market in the world, it makes sense to ensure your chosen partner is FDA compliant:

“For those wanting to launch in the US, your partner should be fully compliant with the FDA's Quality System Regulation (QSR) as outlined in 21 CFR Part 820. You should ensure they are an FDA registered manufacturing establishment with listed products and have a history of successful FDA inspections,” adds Teng Mei Fong.

Have they been routinely inspected by the FDA?

As discussed in our previous blog, not every company who has registered their manufacturing facilities with the FDA, will have actually been routinely inspected by the body.  That increases the possibility that they will have an inspection and receive ‘a finding’ for the first time whilst you are working with them.  So, check before you enter any partnership to understand their current status.

6 essential checks to verify FDA compliance of your medical device contract manufacturer

1. Regulatory compliance verification

• Confirm your company has gained ISO 13485:2016 for their quality management systems
• Verify the FDA registration of their manufacturing facilities 
• Ensure compliance with FDA's Quality Management System Regulation (QMSR)
• Review history of FDA inspections and any resulting 483 observations or warning letters

2. Quality agreement establishment

• Create a comprehensive quality agreement outlining responsibilities for cGMP activities
• Define expectations for product quality and regulatory compliance
• Include provisions for change management and communication protocols

3. Supplier evaluation and selection process

• Assess your manufacturer's quality management systems and manufacturing capabilities.
• Evaluate their expertise in your specific device specialism
• Review their risk management approach and Corrective and Preventive Action (CAPA) processes

4. Ongoing monitoring and audits

• Implement a regular audit program to assess ongoing compliance
• Monitor changes in processes or materials that could impact product quality or safety
• Maintain detailed records of all monitoring activities

5. Change management verification

• Ensure robust processes are in place for managing and documenting changes
• Verify that changes are evaluated for potential impact on product quality and safety
• Confirm necessary regulatory approvals are obtained for any significant changes

6. Documentation and record-keeping assessment

• Review the manufacturer's quality manual and standard operating procedures
• Examine contents of Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR)
• Verify proper documentation of process validations and supplier qualifications

Responsibility for regulatory compliance

Even when outsourcing, OEMs retain ultimate responsibility for ensuring that the final product complies with FDA regulations. This includes making sure that all aspects of the device's design, production, and distribution meet the necessary regulatory standards.

The FDA holds OEMs accountable for any non-compliance, even if it arises from a contractor's action. So make sure that your partner is as open and transparent with you as possible. They should have the tools and processes in place to make your auditing of their quality systems frictionless and hassle-free.

Editor's note: this post is the second in a two-part series. Please click here for part 1.