Services We Offer

Medical Devices & IVDs Services

Our team provides comprehensive support for medical device and IVD manufacturers navigating the complex EU regulatory landscape under MDR (EU 2017/745) and IVDR (EU 2017/746).

We help companies from initial concept through market launch and beyond, ensuring full compliance with European regulations while optimizing time-to-market.

• Regulatory strategy and pathway assessment
• Classification of medical devices and IVDs
• Technical dossier preparation and review
• Quality management system (QMS) implementation
• Post-market surveillance planning
• Risk management (ISO 14971)

Clinical Performance Study & Clinical Evaluation

Expert guidance on clinical performance studies, clinical evaluations, and evidence generation required for CE marking of medical devices and IVDs.

We support manufacturers in planning, conducting, and reporting clinical investigations in compliance with EU MDR/IVDR requirements.

• Clinical evaluation report (CER) preparation
• Clinical investigation planning and protocol design
• Literature review and appraisal
• Performance evaluation for IVDs
• Clinical data analysis and reporting
• PMCF study design and execution

Conformity Assessment by Notified Body

We guide manufacturers through the entire conformity assessment process, from selecting the appropriate Notified Body to achieving CE marking certification.

Our expertise ensures a smooth process, minimizing delays and maximizing the likelihood of successful first-time approval.

• Notified Body selection and liaison
• Pre-submission readiness assessment
• Technical file preparation for NB review
• Response to NB queries and deficiencies
• CE marking certification support
• Certification maintenance and renewals

Post-Conformity Assessment Services

After obtaining your CE marking, ongoing regulatory obligations continue. We provide comprehensive post-market support to ensure continued compliance and market success.

• Post-market surveillance (PMS) system management
• Periodic safety update reports (PSUR)
• Vigilance and incident reporting
• PMCF/PMPF study management
• Regulatory change management
• Market access strategy for EU member states

Clinical Trials

End-to-end clinical trial management for medical devices and IVDs, ensuring regulatory compliance and high-quality evidence generation.

From protocol design through regulatory submission, our experienced team manages every aspect of your clinical program.

Secondary Manufacturing of MD/IVMD

Expert support for secondary manufacturing processes including packaging, labelling, sterilization, and distribution of medical devices and IVDs.

We help manufacturers optimize their secondary manufacturing operations while maintaining full regulatory compliance.

EU Market Access, Clinical Evidence & HTA Support

We support medical device and IVD manufacturers from outside Bulgaria and outside the European Union in building a credible, cost-efficient, and market-oriented route into the EU. We combine regulatory understanding, clinical evidence strategy, and health technology assessment support so that manufacturers can move beyond formal compliance and toward real market access.

The EU market has become more demanding under the MDR and IVDR. Certification timelines are longer, Notified Body capacity remains constrained, and clinical evidence has become one of the main reasons for delay or refusal. For manufacturers outside the EU, the challenge is twofold: achieving regulatory compliance and establishing a credible European evidence and market-access position.

• EU market-access positioning — strategic analysis of regulatory, clinical, and operational activities for efficient entry
• Clinical evidence gap assessment — review of clinical evaluation, PMS, PMCF documentation for CE marking and HTA readiness
• HTA and reimbursement support — evidence-based dossiers translating regulatory documentation into value propositions
• Bulgaria-based evidence generation — leveraging Bulgarian clinical infrastructure, hospitals, and investigators
• Manufacturing and procurement positioning — strategic use of manufacturing presence in Bulgaria for EU tender positioning

Who This Service Is For

Our approach converts MDR-based evidence into a structured and defensible market-access narrative. Instead of treating HTA as a separate late-stage exercise, we integrate it into the broader EU market-entry strategy.

• Manufacturers outside the EU seeking structured entry into the European market
• Companies preparing for CE marking that also need stronger evidence for hospital, payer, or procurement acceptance
• Manufacturers that want to reduce the cost and friction of MDR/IVDR implementation through a Bulgaria-based strategy
• Organisations that need HTA-oriented support built directly on their clinical and regulatory evidence