MD squared certified as Lead Auditor ISO 13485:2016 by BSI

To broaden MD squared's offering in the field of quality management for Medical Devices Claus Schaffrath passed the BSI exam Lead Auditor ISO 13485:2016 after attending a training of one week in Gent, Belgium.  

"When working with my clients on Product Claim Management for their Medical Devices", Claus Schaffrath, Managing Director at MD squared explained, “the structural setup of strong claims often touches regulatory compliance and requires adequate procedures in the quality management system (QMS) of a Medical Device company. After helping some of my clients to develop a risk based QMS approach, which is at the heart of the ISO 13485 standard in its latest (2016) version, I was curious to understand how auditors would look at the ISO 13485:2016. The one week training by the British Standards Institution (BSI) followed by an exam for Lead Auditor ISO 13485:2016 has helped me to gain the perspective of a Notified Body on the adequate implementation of a quality management system for Medical Devices."

Please find the certificate for Lead Auditor ISO 13485:2016 in its English version HERE and in its Dutch version HERE
What we offer

What we offer

MD squared provides the following Services
  • Business Development and Marketing Consultancy for the introduction of novel products and product categories for the Medical Device Industry
  • Medical Support in Regulatory Strategy and Compliance. 
  • Clinical Evaluation & Validation Support and communication with notified bodies and competent authorities.
  • User Needs Assessment and Product Portfolio Analysis for clinical and economic value creation.
  • Clinical Risk-Benefit Analysis and Post-Market Surveillance Plan for Medical Devices.
  • Adverse-Event-Analysis, Mitigation, Reporting and Follow-Up
  • Workshops, Trainings and Seminars on Product Claim Management for Medical Devices
  • Health Technology Assessment and mHealth Compliance

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logo Medical Consultancy for Medical Devices


MD squared
Boerhaavelaan 33

5644BB Eindhoven

The Netherlands

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