Medical Device Regulatory Consulting Services
We bring subject matter expertise to your regulatory compliance
Call us about our Consulting Services +44 114 299 2599 Call Monday-Friday 8am-8pm GMT
-
Clinical Evaluation
- Subject Matter Expertise
- CER & CEP Writers
- Literature Reviews
- Fixed-Cost Pricing
- Notified Body Support
- Tight Deadlines
Market-leading Clinical Evaluation and CER-writing services delivered by MDR-trained medical professionals with extensive data analysis and medical writing expertise.
Learn more about our Clinical Evaluation for Medical Devices service
-
Medical Writing
- Clinical Evaluation Reports & Plans
- Systematic Literature Reviews
- PMCF Regulatory Documents
- Subject Matter Expertise
- Fixed-Cost Pricing
- Tight Deadlines
Regulatory Medical Writing services designed for EU MDR compliance and delivered through the expertise of real medical professionals.
Learn more about our Medical Writing for EU MDR Compliance service
-
Clinical Evidence Generation
- PMCF Studies & Surveys
- Clinical Investigators
- Supporting Documents
- Subject Matter Expertise
- Tight Deadlines
- Fixed-Cost Pricing
Powerful PMCF systems designed by medical experts utilising pre-approved clinical investigators to generate high-quality clinical evidence for your medical device.
-
MDR Academy
- Document Management
- Risk Management
- Quality Management
- Post-Market Surveillance
- Templates Library
- CER Accelerator
Our MDR Academy integrates education, training, support, templates and full document management into a platform which will empower your team to implement critical components of your MDR strategy without the need for outsourcing.
Clinical Investigators & Sites
Our database of pre-approved clinical sites and investigators means we can match your devices with motivated investigators interested in conducting PMCF studies.
-
Extensive database of clinical investigators
-
Pre-approved for PMCF studies
-
Rapid on-boarding & study initiation
-
Access to a broad range of clinical sites
Start today
- Do you need a new regulatory partner?
- Are you starting from scratch?
- Would you like a quote for our services?
Whatever your requirements, contact us today to start your free & confidential consultation.
Call Monday-Friday 8am-8pm GMT
If you have a question for us, you may find it already answered in our FAQs.
Your privacy is important. See how we handle your data.
Get our MDReady Starter Guide A complete starter guide to get ready for the EU MDR
Free download - MDReady Starter Guide Guide See all our downloads