Medical Device Regulatory & Market Access Services

Achieve medical device regulatory approval for UKCA & CE-marking.

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

Market-leading CER & CEP writing services to support UK & EU medical device approvals.

• 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 Notified Body acceptance through expert in vitro diagnostic device regulatory consulting.

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

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

Effectively communicate medical device value to optimise product positioning and drive market share.

• Burden of Disease
• Strategic Market Access Planning
• Evidence Generation Strategy
• Value Proposition Development
• Pricing & Reimbursement Strategy
• Reimbursement Submissions
• HTA Submission Preparation

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