Regulatory Compliance for Medical Devices & IVDs

We offer end-to-end regulatory and quality support for medical devices and in vitro diagnostics (IVDs), ensuring compliance with EU MDR and IVDR requirements and facilitating smooth market access in Europe and beyond. Our services include:

• Technical Documentation & File Preparation
  Preparation, review, and maintenance of comprehensive technical documentation in accordance with EU MDR/IVDR Annexes II & III, tailored to your device classification and regulatory pathway.

• CE Marking & Quality Management System (QMS) Certification
  Guidance through CE marking procedures, including conformity assessment routes, and implementation or optimization of ISO 13485-compliant QMS to meet notified body and regulatory expectations.

• EU Authorized Representative & Person Responsible for Regulatory Compliance (PRRC)
  Provision of EU Authorized Representative services for non-EU manufacturers and appointment of qualified PRRCs as per MDR/IVDR Article 15 to ensure ongoing compliance and regulatory oversight.

• Product Classification & Regulatory Strategy
  Expert advice on device classification and identification of applicable regulatory pathways and standards under MDR/IVDR, including guidance for borderline and combination products.

• Notified Body Selection & Liaison
  Support with identifying, evaluating, and engaging with notified bodies appropriate to your product type and regulatory timelines, including pre-submission communication and audit preparation.

• Risk Management & Biological Safety
  Development and implementation of risk management plans in line with ISO 14971, and support with biocompatibility strategies and testing according to ISO 10993 series.

• Clinical Evaluation & Performance Evaluation
  Preparation of Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) that meet MEDDEV 2.7/1 Rev. 4 and MDCG guidance, with integration of literature reviews, post-market data, and expert input.

• Post-Market Surveillance (PMS), PMCF, and Vigilance
  Design and execution of PMS and PMCF plans/reports, complaint handling procedures, trend reporting, and vigilance systems aligned with EU requirements and best practices.