Your MDR compliance Our medical expertise
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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
MDR Consulting Services
Our team of MDR-trained healthcare professionals are specialists offering tailored Medical Device Regulatory Consulting Services.
Powerful medical device PMCF Studies, Surveys & Plans 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.
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.
MDR Guidance Resources
Our unique MDR Guidance Resources are written by our medical experts and cover all aspects of the new Medical Device Regulation.
Answer 10 quick questions to check whether your medical device needs a PMCF system.
Download our exclusive MDR White Papers, templates, tools and guides.
Our unique EU MDR Compliance Guide covers all aspects of the new Medical Device Regulation.
Keep up to date with our medical team's analysis on the latest MDR news.
Our free webinar gives detailed guidance on building MDR-compliant regulatory systems and processes.
Discuss your MDR requirements with a member of our expert medical team.
Get our free Software as a Medical Device White Paper See whether the EU MDR applies to your application
Keep up to date with our thoughts on the industry. All our articles
Does my medical device need a PMCF system for MDR compliance?
Answer 10 quick questions to check whether your medical device requires a PMCF system.
The impact of Brexit on medical device regulatory compliance
How to ensure regulatory alignment of your devices in the territories affected by Brexit.
Is outside consulting support the answer to your MDR transition?
Getting ready for the MDR is a demanding process. Outsourcing might be your solution.