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.

• Accelerated execution plan
• Get to market 3 times faster
• QMS & regulatory file development
• Supporting SaMD & AIaMD applications
• We guarantee to hit your deadlines

We help US medical device manufacturers leverage existing FDA approvals to accelerate access to UK and European markets.

• Start with a free strategy planning session
• Supporting for both MDR & IVDR certification
• Authorized Representative or PRRC service
• Expertize from experienced professionals
• Accelerate your EU market access

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