ISO Medical Gap Analysis, Certification and Audit Services

When it comes to ISO 13485-2016 standards, WMEP has you covered. We can perform a Gap Analysis, work with your team to the extent you require to achieve certification and conduct Internal Audits. WMEP personnel can work either as a coach or can roll up their sleeves and get the work done.

We can also be your source to conduct an internal audit of your system (Internal Audit Service).

WMEP personnel can work either as a coach or as an active participant in implementing your system.

Benefits of ISO 13485-2016:

  • A management system suited to your organization’s needs
  • Integration of top management into the system to ensure alignment with strategy and accountability
  • Flexibility in documentation
  • Ability to align with other key management system and regulatory standards
  • A systematic approach to risk through your entire management system to prevent issues and ensure continuous improvements and complaint management

WMEP brings a wealth of manufacturing experience and a deep knowledge base in achieving a successful, on-going ISO certification.

  • WMEP can systematically assess gaps and areas of non-compliance via an ISO 13485 Gap Assessment
  • We can lead, assist or conduct a full ISO Certification Implementation Project
  • WMEP can perform a complete ISO 13485-2016: 2015 Internal Audit
Download the WMEP Medical Products ISO info-sheet here.

Get to know Jim Sullivan, Director of Business Development

“The mission and the talent at the WMEP are at the core and helping Wisconsin manufacturers become the best in the world is something I know we can do.”







608.354.1346 [email protected]