Solution driven.
Quality assured.

Medical device clinical investigations without the fuss and worry.
Throughout Europe, Asia, South America and the Middle East.
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Global clinical expertise with local, quality monitoring and project management.

Because medical device clinical investigations are highly specific, our team of experienced, multilingual monitors and project managers are exclusively dedicated to medical devices and work according to our certified ISO 9001 quality system while taking into account cultural nuances to save you critical time and resources for clinical investigation management throughout Asia, Europe, South America and the Middle East.

  • Global clinical strategy development including reimbursement
  • Clinical evaluation report writing
  • Protocol design and development
  • Investigator brochure writing
  • Instructions for use
  • Case report form development
  • Compliant informed consent
  • Site selection
  • Investigator meetings
  • Clinical trial agreements
  • Regulatory and Ethics Committee submissions
  • Clinical project management
  • Product training
  • Site monitoring
  • Site management (CRC)
  • Medical monitoring – Safety reporting
  • Clinical report writing
  • Data management and statistics
  • Clinical auditing
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Market access expertise for fast and smooth sailing across five continents.

Our team of regulatory and quality experts adopt the most cost-effective approach in compliance with local regulations to get your medical device registered rapidly and efficiently. We also offer a range of industry-leading services designed to optimize the positioning of your product.

  • Regulatory strategy development
  • Medical device registration
  • Quality management systems
  • Local representation

Discover how we can get your medical device to market faster:
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Our regulatory network

Our international regulatory expertise spans the following countries:

  • Argentina
  • Australia
  • Brazil
  • Chile
  • China
  • Europe
  • Hong Kong
  • India
  • Indonesia
  • Israel
  • Malaysia
  • Mexico
  • Myanmar
  • New Zealand
  • Philippines
  • Saudi Arabia
  • Singapore
  • Taiwan
  • Thailand
  • Vietnam
  • USA

Our Expertise

Clinical Investigations/Clinical Evaluations

The need for pre- and post-market clinical data is an unavoidable regulatory requirement in most countries in the world today. Through 30 years of expertise in the global medical device industry and having conducted over 200 trials from pilot to pivotal and post-market surveillance, our team works with clients to define the optimal clinical strategy for their devices and executes any clinical trial activity where needed.

You can rely on our clinical and engineering experts to write effective clinical evaluation reports whether for direct regulatory approval or as a basis for setting up the scope of a prospective clinical investigation.

We keep up-to-date on the regulatory requirements in European, Asian, South American and Middle East countries to start clinical investigations, allowing us to significantly optimize your clinical trials from the start and manage compliance throughout the investigation with focused medical device expert monitors and project managers.

MD-CLINICALS has distinguished clinical strategy development methods by involving reimbursement experts early on to prepare our client's market access with health economics data that contribute significantly to early sales targets once the product is on the market.

Our Team

Danielle Giroud

Founder, CEO

With over 20 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO). Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe.

She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission - CIE (Clinical Investigation and Evaluation) task force.

Tan Hwee Ee

Senior Consultant Asia, Regulatory & Quality Assurance

Ms. Tan has 20 years of experience in the medical industry principally in medical device organisations as a consultant, engineer and senior manager. She has several product certifications under her belt compliant with global regulatory systems 21 CFR part 820, ISO 13485, Asia GDMP. Ms Hwee accompanies your product development for market access in Asia, US and Europe.

Ms. Tan has a wealth of expertise that she translates into comprehensive training courses whether in house, online or at seminars. She is also a member of Working Group 6 (WG6) of the AHWP (Asian Harmonization Working Party).

Greg Sachs

Senior Consultant US, Regulatory & Quality Assurance

For over 25 years, Mr. Sachs has brought medical device products to the global market as a leading expert in regulatory and clinical affairs, quality assurance, and product development. His broad experience includes development of corporate strategic plans, national and international regulatory, quality, clinical planning and submissions, CE-mark, successful market introduction of proprietary technology, as well as budget/product management.

Mr. Sachs has published numerous research articles in several leading medical journals and is a member of the Regulatory Affairs Professional Society, the American Society for Quality Control and the World Medical Device Organization.

MD-CLINICALS: Your partner for medical device clinical investigations and market access throughout Europe, Asia, South America and the Middle East.

If you have a question or are interested in any of our services, please contact us.