Regulations and Standards

Compliance

I support organisations in understanding, implementing and maintaining compliance with applicable regulatory and quality requirements within Medical Devices, IVD and Pharmaceutical Primary Packaging.
My experience includes both interpretation of requirements and hands-on implementation across Quality, R&D and Operations.

Areas of Support

I can support organisations with:

  • MDR and IVDR compliance
  • Regulatory gap assessments
  • Implementation of new or changed requirements
  • Technical Documentation
  • Design Control related compliance activities
  • Quality Management System requirements
  • Requirements for importers, distributors and other economic operators
  • Product classification and regulatory assessments
  • Implementation and improvement of compliance processes
  • Training and knowledge transfer

Medical Devices and IVD

A significant part of my consulting work has involved implementation and interpretation of requirements related to the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
My experience includes supporting organisations with assessment of applicable requirements, gap analyses, implementation activities and preparation or improvement of documentation required to demonstrate compliance.

Pharmaceutical Primary Packaging

My background also includes 16 years of experience within Pharmaceutical Primary Packaging, where I worked with Quality and Regulatory requirements in an international manufacturing environment.
This includes experience with ISO 15378, GMP-related requirements and regulatory requirements applicable to primary packaging for medicinal products.

Regulatory and Quality Frameworks

My experience includes working with requirements related to:

  • MDR
  • IVDR
  • ISO 13485
  • ISO 14971
  • ISO 15378
  • Other applicable regulatory and quality requirements

Practical Implementation

Compliance is not only about understanding the requirements. It is also about translating them into processes, documentation and ways of working that can be implemented effectively in the organisation.
My approach is pragmatic and proportionate, with focus on achieving compliance without unnecessary complexity.

If you would like to discuss a compliance challenge or a potential assignment, you are welcome to contact me.