ISO 13485:2016 Support

QMS Support ISO 13485

Manufacturers and related organizations in the niche of medical technology and or life sciences (i.e. bio tech, medical devices, in vitro diagnostics, etc.) face global demands to streamline and standardize their processes. They must establish and maintain an adequate quality management system, perform frequent audits, and continually adapt to changing regulatory requirements. Examples are

  • the revisted ISO 13485:2016
  • changing roles of Notified Bodies (unannounced inspections)
  • the revision and additional regulatory requirements of the European Medical Device Regulations (MDR - MDD / IVDR), such as i.e. UDI, Clinical Evaluation Reports, PMCF-reports, control of supply chain, etc.

MRM offers organizations a structured and effective method for implementing a quality management system compliant with

  • ISO 13485:2016 and or
  • FDA's Quality System Regulation (21 CFR 820) and or
  • SOR/98-282 (Canada) and or
  • European CE marking of medical products (MDR / IVDR).

Publication ISO 13485:2016

The 'new' ISO 13485:2016 will be properly published somewhere in March or April 2016. In fact, we expect  publication around the same time as the publication of the revisited European Medical Device Regulations (MDR) and the revisited In Vitro Diagnostic Regulations (IVDR). The impact of the changes of MDR and the IVDR will be significant and requires higher investments from medical device manufacturers and other companies to be in compliance with the new EU regulations & requirements. 

Companies, in particularly manufacturers, need to anticipate and prepare to deal with proposed changes in a pro-active and timely manner to avoid having CE certificates suspended or revoked. We advise you to be prepared on time!

GAP Analysis

Our GAP analyses will provide your organization with

  • an understanding of your current level of compliance,
  • identify opportunities for further improvement, and
  • develop a path forward to (re)certification ISO 13485:2016.

Our full service program guides organizations through the development, implementation, and registration of a compliant quality management system. This program also defines the internal and external resources required to achieve certification.

Why choose MRM?

We have assisted multiple organizations in attaining and maintaining certification to ISO 9001, ISO 13485 and the FDA’s QSR.

What distinguishes our approach is our focus on both performance and conformance. We use the certification process as an opportunity to analyze your processes with the goal of improving them before they are standardized and documented. While this approach may take slightly longer than others, the small investment of time will yield opportunities to improve organizational performance. These recommendations provide a tangible ROI for the initiative, ultimately improving shareholder value and customer satisfaction.

MRM's - Consulting

Our goal is to transfer knowledge to your organization, so you remain successful after we leave. This approach works. We believe in our methodology and In some situations we offer 'no cure no pay'. 

'Integral Integrated Business Solutions'

Our 'Integral Integrated Business Solutions' (IIBS) services is all about implementing adequate systems that add value, remove waste and provide connectivity within your organization. Our focus is to ensure both operational activities and systems function effectively.

IIBS combines planning, training, and follow-up consultation to ensure all activities related to a successful quality system (ISO, QSR), technical file (CE-mark, 510-k) and or Post Market Clinical Follow Up (PMCF) are effectively implemented.

Contact us to see how we can help.


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