Medical Device Regulatory & Market Access Services

Tailored support to secure UKCA or CE-marking for your medical devices.

• Technical File Production
• Clinical Evaluation
• Systematic Literature Reviews
• Risk Management
• Clinical Strategy Development
• PMS & PMCF
• Quality Management Systems
• Further MDR Services

CEP & CER writing services with success across 250+ submissions spanning all risk classes.

• Validated & verified CE Process with 100% acceptance
• CERs & CEPs for UK & EU MDR compliance
• Complete MedDev & MDCG alignment
• Fully qualified CER signatories
• Unlimited post-submission support until full approval

Ensure your in vitro diagnostic medical devices gain first-time IVDR approval.

• Technical File Production
• Performance Evaluation Reports
• Systematic Literature Reviews
• Risk Management
• PMS & PMPF
• Quality Management Systems
• Further IVDR Services

Software as a Medical Device support for high-velocity medtech teams where time-to-market is existential.

Full service MDR / IVDR consulting for a single, all-inclusive monthly fee.

• Tailored MDR / IVDR support
• UKCA and CE-marking on your terms
• Predictable & transparent pricing
• No minimum term
• All-inclusive support

Ensure validation & verification to harmonised standards through a network of trusted partners.

• Biocompatibility Testing
• Usability Testing
• Electrical Equipment Testing
• Packaging Standards Testing
• Other testing services