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We work with medical device companies across the industry ranging from pre-start businesses to stockmarket-listed multinationals. We also have strategic partners throughout Europe.
I really appreciated your job on our medical device CER. It was truly amazing how you managed to get all this done in such a short notice. I'm very pleased with your work.CEO, Medical device company, France
It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.CEO, Medical device software company, Denmark
Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.CEO, MedTech pre-start, UK
A comprehensive, detailed and highly professional service.Regulatory Manager, Medical device company, UK
We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.
Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.
Read more about our team and philosophy
Supporting your medical device compliance
- Products matched to expert clinicians with real subject matter expertise
- Market-leading Clinical Evaluation & Medical Writing professionals
- Powerful medical device PMCF Plans, Studies & Surveys
- Identification, analysis & production of clinical evidence
- Extensive MDR Training & Guidance Resources
- Comprehensive Data Analysis services
MDR Consulting Services
Our team of MDR-trained healthcare professionals are specialists offering tailored Medical Device Regulatory Consulting Services.
Powerful medical device PMCF Plans, Studies & Surveys designed by medical experts and driven by leading-edge eCRF, ePRO and data storage systems.
Market-leading Clinical Evaluation and CER-writing services delivered by MDR-trained medical professionals with extensive data analysis and medical writing expertise.
Special SaMD applications of our PMCF, Clinical Evaluation, Medical Writing and Evidence Generation services address the unique challenges of applying MDR requirements to medical software.
Specialist Medical & Technical Writing services designed for MDR compliance and delivered through the expertise of real medical professionals.
Identification, appraisal and analysis of medical device clinical evidence conducted by professional medical experts and refined for MDR compliance.
Get our free White Paper: PMS in the MDR — A complete summary on medical device Post-Market Surveillance
Our MDR Training Academy runs events designed to quickly and effectively fill gaps in your MDR knowledge-base.
Online workshop MDR Compliance for CEOs/CFOs
5th May 2021 @ 12 noon GMT
A workshop designed for senior company decision makers to help them understand MDR compliance strategy and what it means for their company.
Online workshop Software as a Medical Device
12th May 2021 @ 12 noon GMT
Learn how to apply the MDR to Software as a Medical Device to ensure regulatory approval and protect your market position.
Online workshop Clinical evidence in the MDR
19th May 2021 @ 12 noon GMT
Learn how to use clinical evidence in MDR Gap Analysis, PMS, PMCF & Clinical Evaluation and apply this to your MDR compliance strategy.
Online workshop MDR Compliance for Class I devices
26th May 2021 @ 12 noon GMT
Understand the specific MDR compliance requirements for Class I medical devices and how they differ from those under MDD.
MDR Guidance Resources
Our unique MDR Guidance Resources are written by our medical experts and cover all aspects of the new Medical Device Regulation.
Get our White Paper: Software as a Medical Device — See whether the EU MDR applies to your application
Keep up to date with our thoughts on the industry. All our articles
Is outside consulting support the answer to your MDR transition?
Getting ready for the MDR is a demanding process. Outsourcing might be your solution.
Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
Simplifying the challenges posed by the new EU MDR
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the EU MDR.