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Regulatory Services

We provide high-quality, reliable regulatory services to support your company throughout the entire product lifecycle, from early-stage development to post-market activities. With strong expertise in all types of Medical Devices and IVDs we assist manufacturers with EU and US regulatory submissions including substance-based devices, combination products and devices without an intended medical purpose.

Our real-world data collection strategies for the post-market phase, supported by innovative digital solutions, boast the collection of useful data for supporting the safety and the performance of the product.

A well-designed regulatory strategy is crucial for successful and time-saving product certification. We support our customers in translating regulations into tailored strategies that comply with European and international standards, considering development costs and regulatory cycles. Our services encompass the preparation of complete Technical Documentation, putting together, within a comprehensive risk management process, all the pieces of the regulatory mosaic, including: clinical evaluation strategy, biological evaluation, usability assessment, post-market clinical follow-up and post-market surveillance activities.

We offer turn-key services.

As a CRO specialized in MedTech, we offer support across all stages of a product’s lifecycle, from preclinical assessment to pre-market clinical trials, all the way to CE marking and post-market surveillance activities.

Real World Data collection – 1Survey+

MDR expert support

IVDR expert support

Gap analysis for compliance with new Regulation 2017/745 on Medical Devices (MDR) and new Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR)

Regulatory strategy for CE mark: device classification, identification of applicable requirements, technical standards, preclinical and clinical studies for CE marking according to MDR and IVDR

Regulatory strategy for FDA approval, FDA applications for pre-IND, IND, IDE, 510(k) and PMA.

Q-sub, Breakthrough designation

Notified Body selection and liaison

Technical documentation preparation and maintenance (Technical File/Design Dossier, e-TF) MDR-compliant and IVDR-compliant

Product’s leaflet and labels texts preparation and review

Scientific Literature Review

Clinical Evaluation File according to Article 61 and Annex XIV of the MDR Current Edition and MDR

Post-Market Surveillance (PMS) and Periodic Safety Update Report (PSUR)

Post-Market Clinical Follow-up (PMCF)

Post-Market Vigilance (PMV)

Support to Company’s Risk Management Team for medical device risk analysis according to ISO 14971

Support in the completion of Design History File (DHF) and Device Master Record (DMR)

Interaction with Notified Bodies and Competent Authorities during certification processes

Support for medical devices worldwide registration and registration maintenance

Cosmetic Product Information File (PIF)

Ensuring Continuous Compliance

Navigating the complexities of medical device regulations can be a challenging journey dealing with constant evolving requirements. 1MED’s Regulatory Intelligence team ensures an up-to-date compliance review process within the dynamic regulatory framework while anticipating potential issues and changes.

Expert Liaison with Regulatory Bodies

We provide tailored solutions in negotiating with Notified Bodies (NBs), FDA, EMA and international regulatory agencies. Our expertise enables the preparation and submission of reviewer-friendly technical documentation, facilitating smooth interactions with NBs and Competent Authorities (CAs).

Proven Success in Regulatory Approvals

100% success rate in certifying over 300 medical devices. Our experience with international and start-up companies, coupled with interactions with Competent Authorities and Notified Bodies, underscores the importance of understanding both the technological requirements and related patient benefits.

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