Thinking ahead and beyond makes the difference

Practical regulatory and quality support for the medical device industry

Introduction

Founded by Arjan Knipmeijer on 1 October 2026, Villa Medica brings more than 28 years of Notified Body experience directly to medical device manufacturers worldwide.

Throughout my career, I have worked with both the Medical Device Directive 93/42/EEC and the Medical Device Regulation (EU) 2017/745. I understand the regulatory challenges manufacturers face and the importance of finding a clear, workable path forward.

Villa Medica provides tailored quality management system (QMS) and regulatory support to help you address those challenges and progress towards your goals.

Our approach

“Thinking ahead and beyond makes the difference.”

Regulatory compliance is essential. Achieving it also calls for a thoughtful, practical approach—one that considers your products, processes and business objectives. There may be more than one way to reach a regulatory goal. I work with you to identify a suitable way forward while keeping the applicable requirements in focus.

I believe strong results come from close, trusting partnerships, clear communication and a shared understanding of your priorities. My aim is to provide responsive support and practical strategies shaped around your needs.

How I can support you

I work with medical device manufacturers, including start-ups and small and medium-sized
enterprises, that need experienced support with quality systems and regulatory matters.

Support may include:

  • Reviewing technical documentation and identifying areas to address for MDR conformity assessment.
  • Assessing QMS processes against relevant regulatory requirements.
  • Developing regulatory road maps for product certification and international market registration.
  • Helping manufacturers prepare to work with European Notified Bodies and other regulatory organisations.
  • Connecting clients with suitable subject matter experts and international service providers when specialist input is needed.
  • Coordinating input from clinical research organisations (CROs) and other consultancy or development partners.

Every engagement begins with a discussion and is shaped around your needs, products and objectives.

Two areas of focus

Villa Medica’s work brings together two complementary areas:

  1. Regulatory liaison — supporting communication and cooperation with European regulatory organisations, including Notified Bodies, medicines agencies, the European Medicines Agency (EMA) and Competent Authorities.
  2. Manufacturer support — working directly with medical device manufacturers on QMS and regulatory matters.

Villa Medica operates independently. The scope of support is agreed directly with each client.

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