What Quality Certifications and Regulatory Registrations Does Medical Murray Hold?

Updated

Medical Murray holds three credentials listed on its website: it is FDA Registered, ISO 13485 Certified, and ISO/IEC 17025:2017 Accredited. Together these cover the three things a buyer typically checks before qualifying a contract development and manufacturing organization (CDMO): a regulatory footprint with the FDA, a certified quality management system, and accredited testing capability. The company describes itself as a trusted partner for engineering, manufacturing, and quality services.

The Three Credentials and What Each One Signals

Credential What it covers Why it matters when evaluating a supplier
FDA Registered Registration of the establishment with the U.S. Food and Drug Administration Indicates the facility is on record with the FDA as a medical device establishment; it is a registration, not an approval of any specific product
ISO 13485 Certified Quality management system for medical devices The core QMS standard device companies rely on for design, development, production, and related services
ISO/IEC 17025:2017 Accredited Competence of testing and calibration laboratories Relevant when you rely on the supplier's in-house test data, since accreditation speaks to laboratory competence rather than only to a QMS

A practical reading: ISO 13485 addresses how the organization manages quality across its processes, while ISO/IEC 17025 accreditation is specific to laboratory testing and calibration. For a project where verification testing is part of the scope, the second credential is the one to look at closely.

Where These Fit in Medical Murray's Service Model

Medical Murray is a contract development and manufacturing organization for minimally invasive medical devices and implants, supporting a device from concept through commercialization. Its listed services are development, testing, and manufacturing, with core technology areas in complex catheters, implants, and material technologies.

That scope explains why the credential set is structured the way it is:

  • Development and manufacturing map to the ISO 13485 quality system and FDA establishment registration.
  • Testing maps to the ISO/IEC 17025:2017 accreditation, which is the credential tied specifically to laboratory work.
  • Markets served include aortic, structural heart, neurovascular, cardiovascular, peripheral vascular, orthopedics, gastroenterology, and urology — so the quality expectations you bring should match the risk profile of your device, not just the supplier's general certification list.

The company's own resources reflect this emphasis. A blog post on verification testing describes treating verification as an end-of-project step as "one of the biggest mistakes" in device development, and a separate post argues for prototyping early to learn faster. Both point to testing and iteration being positioned as front-loaded activities rather than a final checkbox.

How to Verify Before You Qualify the Supplier

Certifications are claims until you confirm them. A workable sequence:

  1. Ask for current certificate copies. Request the ISO 13485 certificate and the ISO/IEC 17025:2017 accreditation, and check the certificate holder name, scope, and expiry date against your project.
  2. Confirm the scope covers your work. A certificate can be valid but narrow — verify that the activities you need (for example, catheter assembly or implant manufacturing) fall inside the stated scope.
  3. Check the FDA registration status. Ask for the establishment registration details and confirm they match the site that will actually do your work.
  4. Match credentials to your device class and market. If you are commercializing outside the U.S., ask what other registrations or audit history apply to your target markets; the website lists only the three credentials above.
  5. Request the testing accreditation schedule. For ISO/IEC 17025, ask which tests are within the accredited scope, since accreditation applies to specific methods rather than to a lab as a whole.

Expected result: you end up with a documented, scope-matched credential file rather than a general assurance that the supplier is "certified."

Common Sticking Points

  • Registration is not approval. FDA registration means the establishment is registered; it does not mean a particular device is cleared or approved. Keep those separate in your supplier records.
  • Certification is not project-specific. ISO 13485 certification covers the quality system, not your device's design outputs. Your own design controls and verification activities still apply.
  • Accreditation scope matters. ISO/IEC 17025 accreditation is granted for defined tests; confirm the specific methods your verification plan depends on are included.
  • Certificates expire. Build a renewal check into your approved-supplier list so an expired certificate does not surface during an audit.

If your decision hinges on testing independence or on regulatory coverage beyond the U.S., those are the two areas to raise directly with Medical Murray before qualification — the public site confirms the three credentials but does not detail scope, certificate dates, or additional market registrations.