MedAccred: Standard for Production of Medical Devices

MedAccred is a standard developed by the Performance Review Institute (PRI) ^[1] that encompasses the entire supply chain for the production of medical devices. It focuses heavily on aspects of critical manufacturing, or those that have a direct impact on the safety, effectiveness, and quality of the final product.

PRI offers MedAccred certifications in the following areas:

• Cable and wire harnesses
• Heat treatment
• Plastic extrusion
• Plastic injection molding
• Plastic mechanical assembly
• Printed boards
• Printed circuit board assembly
• Sterile device packaging
• Sterilization
• Welding

A MedAccred certification is not mandatory, but is medical device companies (known by PRI as “subscribers”) often require it for their suppliers. The standard is also internationally recognized, leading many organizations to consider it a de facto certification. As such, a MedAccred certification is extremely valuable in the medical device industry.

Typically, subscribers recommend MedAccred certification to their suppliers. The supplier then works with PRI to schedule an audit from an approved auditor. PRI and the subscriber will consult on the outcome of the audit, after which PRI will issue a MedAccred certification to the supplier.

MedAccred certifications are usually valid for three years, after which time suppliers must undergo another audit. If passed, the supplier will be recertified.

Adhering to MedAccred standards offers several benefits to organizations. Some key advantages include the following.

Implementing MedAccred standards may pose several challenges to organizations. They include the following.

Here are a few tips for preparing for a MedAccred certification:

• Download the MedAccred brochure
• Familiarize yourself with PRI’s online audit management system
• Attend a PRI audit preparation training course

For more information and guidance on MedAccred certification, you can refer to the following resources.

Performance Review Institute. The PRI’s website should be the first stop for organizations seeking MedAccred certification. There, you can find a wealth of resources related to MedAccred, as well as request a quote for an audit or sign up for an audit preparation course.

Manufacturing skills matrices. AG5 offers free, industry-specific skills matrices dedicated to various manufacturing practices. You can use them to identify, track, and manage skills related to a MedAccred certification in your organization. 

ISO 9001 certification guide. AG5 offers a free certification guide for ISO 9001 – a standard organizations often use as a starting point when seeking MedAccred certification.