Regulatory solutions for medical devices and IVDs

Navigating the complexities of medical device and in vitro diagnostics regulations can be challenging for manufacturers, importers and distributors. Ramboll offers tailored advice to help clients prepare essential technical documentation (TD) for successful market approval, adhering to specific regulations and laws throughout all stages of the product lifecycle.

Our support throughout the MD lifecycle

With the right guidance, securing market access and maintaining compliance becomes straightforward. We develop international market access strategies and provide comprehensive TD support.

Our services at a glance:

• Globally compliant quality management systems (QMS)
• Risk management according to ISO 14971
• Biological evaluation/biocompatibility in line with ISO 10993
• Clinical evaluation and literature research
• Performance evaluation for IVDs

Globally compliant quality management systems (QMS)

Implementing a robust QMS is crucial for compliance with ISO 13485 and other standards and is mandatory for manufacturers of medical devices.

Ramboll assists with:

• Creating and maintaining QMS documents.
• Developing quality policies, including planning and goals, and identifying key performance indicators to enable an objective process evaluation.
• Gap analyses and research into standards, internal and external auditing.
• Hands-on support in process optimisation, monitoring and documentation.
• Providing EUDAMED guidance.

Risk management according to ISO 14971

The risk assessment procedure is outlined in ISO 14971 and further detailed in ISO/TR 24971, whereby risk management is a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. Comprehensive risk management provides clients with valuable insights on how to develop medical devices that perfectly fit the needs of users and patients.

Ramboll assists with:

• Developing risk management procedures aligned with requirements and accepted worldwide to help clients minimise costs and time.
• Providing and customising risk management forms in line with ISO 14971:2019 and ISO/TR 24971:2020 and advising on their completion.
• Training and moderation of risk assessment meetings.
• Supporting specific queries and deviations.

Biocompatibility in line with ISO 10993 standards

Biological evaluations – biocompatibility – of medical devices are risk management activities that require advance planning in accordance with ISO 10993-1. Ramboll guides you through the process, including the preparation of the biological evaluation plan (BEP), laboratory tests, toxicological risk assessment (TRA), and compiling the final biological evaluation report (BER).

Under ISO 10993-1:2025, manufacturers must evaluate biological risks across a product's entire lifecycle, consider reasonably foreseeable misuse, and implement new contact category definitions. Every evaluation begins with an analysis of the available data (chemical and physical information, biological tests, and post-market surveillance (PMS) data), followed by a customised toxicological risk assessment that help companies save time and costs by preventing unnecessary in vivo or in vitro testing.

Our expertise includes:

• Risk-based planning of biological evaluations according to ISO 10993-1:2025 and country-specific regulations (eg US FDA requirements), independent from laboratory capabilities.
• Guidance and monitoring services for chemical characterisations (ISO 10993-18:2020 + Amd 1:2022) and biological tests.
• Database, literature and in silico based toxicological risk assessments of extractable constituents according to ISO 10993-17:2023.
• Expert biological evaluation reports from certified and registered toxicologists.

Ramboll has experience collaborating with laboratories to provide test packages (such as chemical characterisations, cytotoxicity, sensitisation, irritation, systemic toxicity, local effects after tissue contact, genotoxicity, carcinogenicity, haemocompatibility).

We are experts in dealing with substances of concern, nanomaterials and other critical materials such as per- and polyfluoroalkyl substances (PFAS) and microplastics. We provide sustainable strategic solutions that extend far beyond standard evaluation approaches.

Clinical evaluations for EU-MDR compliance

Manufacturers of medical devices destined for the European market are obliged to perform clinical evaluations in line with the EU Medical Device Regulation 2017/745 (EU-MDR) Article 61 and Annex XIV, multiple Medical Device Coordination Group (MDCG) guidance documents, and the MEDDEV 2.7/1 revision 4 guideline.

Successful clinical evaluations depend on properly defining the required level of clinical evidence and selecting the appropriate performance and safety requirements. Ramboll combines high-level consensus state-of-the-art (SOTA) literature with comprehensive searches of clinical trials using meta-databases to ensure that all relevant studies are captured and the evaluation is supported by the most robust clinical evidence.

We assist with:

• Preparing or updating clinical evaluation plans (CEP), literature search, and clinical evaluation reports (CER), including post-market clinical follow-up (PMCF).
• Providing expert support for in-house literature search and the clinical evaluation process.
• Addressing deviations identified by notified bodies.

If clinical investigations are required, Ramboll can help find a competent partner.