MedAccred: Standard for Production of Medical Devices

MedAccred is an accreditation program focused on the production of medical devices. In this guide, we will explore the key aspects of MedAccred certification, including its significance, steps required for certification, benefits of implementation, and more.

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MedAccred certification guide

What is MedAccred? Copied

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

Who needs a MedAccred certification? Copied

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.

How to earn a MedAccred certification Copied

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.

Renewal requirements for MedAccred certification Copied

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

The benefits of MedAccred certification Copied

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

Improved process efficiency

MedAccred standards streamline medical device component suppliers’ critical processes, reduce redundancies, and optimize workflows. This, in turn, can lead to faster production cycles and better resource utilization.

Improved product quality

MedAccred’s stringent quality control measures help ensure that you are adhering to industry best practices. This results in higher-quality – and more reliable – components and assemblies.

Reduced waste

Adhering to MedAccred standards minimizes chances of errors and defects – and thus scrapping or reworking of parts, components, or assemblies. This not only works to improve product quality, as described above, but helps reduce waste and save costs.

Challenges in earning a MedAccred certification Copied

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

Documentation requirements

Meeting MedAccred’s documentation standards requires meticulous record-keeping and process documentation. Ensuring accuracy, completeness, and traceability here can be challenging.

Specialized training

MedAccred often requires employees to receive specialized training in critical manufacturing processes. Obtaining and maintaining expertise in specific manufacturing techniques, testing methods, or compliance requirements can be time-consuming and costly.

Audit preparation

To adequately prepare for a MedAccred audit, organizations must ensure that all processes, procedures, and facilities align with MedAccred’s standards. This usually extensive planning, resource allocation, and continuous monitoring.

Tips and strategies for earning a MedAccred certification Copied

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

Resources for MedAccred certification Copied

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.

Skills management for MedAccred certification Copied

AG5 stores all certifications in the cloud, providing all authorized personnel with access to the right version of approved certifications. This helps you easily keep track of all data and documentation related to MedAccred certification across your organization.

Using AG5’s skills management software, you can monitor the status of any type of certification that is relevant to your workforce, leveraging intuitive dashboards that provide you with a clear understanding of exactly what is needed to keep your employees skilled and safe.

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Frequently asked questions about MedAccred Copied

  • What is the scope of a MedAccred certification?

  • Is MedAccred certification mandatory?

  • How long does it take to obtain a MedAccred certification?

  • What are cost considerations for a MedAccred certification?

  • What is the validity period of a MedAccred certification?

  • Can MedAccred be integrated with any management systems?

  • How can you learn more about ISO 14001 certification?

Sources Copied

Source title Description Date retrieved Source URL
MedAccredPerformance Review Institute7 May 2024 16:17:03

Author Copied

Revisions Copied

Original version | May 7, 2024

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