Client Testimonials

Medical Device Consultants

We are experienced consultants whom have helped our clients bring medical device products to the UK and EU Markets. We work with both large and small companies, ensuring results for their projects.

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What our clients say...


NPD consultants have been instrumental in our regulatory compliance journey from our initial CE and ISO13485:2016 MDD certification to the attainment of MDR. They have diligently and methodically guided us through the establishment of our quality management system and technical file, taking us from ‘zero to one’ as we entrepreneurially took our innovation into medical device production.

 

Subsequently, they have worked with us to provide specialist knowledge, planning and quality assurance of our structure, evidence and control in microbiology, clinical and technical build and assessment of our quality management system and technical file to MDR standards and certification.

 

We hugely appreciate the contribution that both Karen and Martin make and greatly appreciate the way they integrate and work with our team. I hope and fully intend for NPD Consultants to remain our long-term regulatory support and advisory partner and would fully recommend their services to others. 


Michael Wilshaw, Managing Director


I have worked with NPD consultants since 2024 and always found them to be professional, diligent and approachable. They respond very quickly to our requests and I can always send the difficult questions their way with a guarantee of a pragmatic and sensible regulatory strategy to approach a problem.

 

I find both Karen and Martin to have excellent regulatory and technical knowledge and they have been able to assist with a wide range of issues including microbiology, manufacturing, sterilization, method validation and Post Market Surveillance and Clinical evaluation.

They were instrumental in us obtaining our first MDR certificates and continue to support us as we grow our in-house expertise.


Lindie T, Senior Technical & Regulatory Manager


I have worked with NPD Consultants since stepping into the role of Head of Compliance, and they played a crucial part in supporting our transition to the EU MDR. They managed all communication with our Notified Body and consistently delivered pragmatic solutions — ones that ensured full compliance while supporting our operational requirements.


Their depth of knowledge is extensive, and on the rare occasion they don’t have an immediate answer, they take the initiative to research thoroughly and provide well‑founded guidance.


They are both friendly and highly professional, and it has been a genuine pleasure working with them.


Kirren J, Head of Compliance


We greatly appreciate the expertise and support provided by NPD Consultants throughout our transition from MDD to MDR. Their technical and regulatory guidance was consistently clear, pragmatic, and reliable, ensuring our technical and clinical documentation met all requirements without unnecessary delay or complexity. In addition, their in-audit support for both ISO 13485 and ISO 9001 was exceptional - calm, knowledgeable, and instrumental in helping our team navigate challenging discussions with confidence.


NPD Consultants have been a trusted partner at every stage of the process, and we would highly recommend them to any organisation seeking dependable regulatory and quality management support for medical devices.


Jackie B, QHSE Manager & Jade P, Regulatory Affairs Manager


I am pleased to provide a testimonial for NPD Consultants Ltd (NPD), who provided medical device regulatory services to Alacramed Ltd from 2016 to 2023 (as associate consultants). This service ended due to a planned winding down of Alacramed.


During the time that I worked with NPD I found them to be:

  • Extremely knowledgeable in the field of medical device regulation, and diligent in keeping up with changes in the regulations as they happened.
  • Timely in the preparation of reports and the provision of guidance on medical device regulatory strategies, for often complex scenarios.
  • Very capable in their engagement with regulatory bodies and organisations necessary to gain regulatory clearance for medical devices.
  • Personable, and able to build good working relationships at all levels in organisations.


Overall, from my experience of working with NPD, I would highly recommend them as a medical device regulatory consultancy.


Mark Wickham, Director

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