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.
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.
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.
We offer turn-key services.
We support our clients through 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.
Our regulatory services include:
Our regulatory services include:
- 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. Our 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).