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Medical Device CDMO and Critical Supplier QMS Audits

Virtually every medical device manufacturer depends on outside suppliers. Some provide critical components, others do final assembly. How do you know if their delivered products consistently meet your specifications? Does their QMS continue to function effectively? Will your quality management program withstand scrutiny from regulators? Supplier audits are the most efficient way to ensure that what you specified is what you received.


How We Help

Trust But Verify: Making Sure Your Suppliers Deliver What They Promised

You can outsource manufacturing but you can't outsource your responsibility to comply with regulations. Even if your design and device manufacturing is 100% outsourced, it’s YOUR responsibility to ensure that your subcontractors are also complying with relevant medical device standards and regulations. This is both good business and a requirement of ISO 13485, FDA 21 CFR Part 820, and other international standards and regulations.

The good news is that you don’t have to do it alone. Many internal QMS teams simply don’t have the bandwidth to audit their suppliers on a regular basis and that’s where we can help. Our experienced QMS auditors can help you:

  • Identify medical device CDMO strengths, weaknesses, nonconformities, and opportunities for improvement.
  • Ensure that suppliers consistently comply with the requirements specified in supplier agreements and relevant standards or regulations.
  • Increase efficiency and save money by addressing quality at the root (supplier) level and preventing problems from recurring.
  • Develop a risk-based supplier audit program that supports your compliance but doesn’t weigh down your QA budget

Getting Your Non-Compliant Suppliers Into Compliance

Additionally, we can work with you to design a program to “develop” key suppliers that do not meet your requirements. This program can include the development of simple management systems or could include the implementation of robust improvement methodologies such as Lean or Six Sigma. For each supplier there can be a supplier development plan that is unique to the needs of the supplier and the critical nature of the parts being supplied.

Our Lead Auditors Are Located Worldwide

Regardless of where your suppliers or CDMO are located we're ready to help. Our auditors are located throughout the US, Europe, Latin America and Asia, and specialize in ISO 9001, ISO 13485 and FDA QSR compliance. Our teams has performed hundreds of CDMO supplier audits for small medical device companies and multinationals alike.

We’re Ready to Help

Oriel STAT A MATRIX has worked with thousands of medical device and IVD manufacturers on supplier audits on supplier improvement programs. Let’s discuss your situation and see if we can assist.

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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