Repository of EU Regulatory Support

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Disclaimer – The repository of the EU Regulatory support provides a non-exhaustive list of organizations that provide support in the field of the European regulations MDR/IVDR. The organisations that are listed are those that the NOBOCAP consortium became aware of using desk research or by a request of the organization itself. No selection criteria apply nor does any quality check apply. Nobocap does not take any accountability for the accuracy of the data provided but seeks to offer an overview of organisations that might be contacted.  Of this repository, several organizations are members or knowledge-know-how partners of our community to unlock the EU regulations (see https://nobocap.eu/nobocap-membership/). This listing is free of charge at all times. At all times organizations can decide if they want to be delisted.

Company name/ Initative name 

Short description of services

Country

Covartim

Covartim offers services related to EU regulations, including assistance in research and development (R&D), quality assurance, and regulatory affairs within medical devices, in vitro diagnostic (IVD) medical devices, and Digital Health solutions.

BELGIUM

DM Experts SAS

DM Experts SAS specializes in EU-regulation related services, offering training on MDR and IVDR (available through e-learning, live sessions, or on-site training) as well as other topics such as sterilization and artificial intelligence. Additionally, the company provides regulatory and standards intelligence through a monthly newsletter and consulting services.

UNITED KINGDOM

IMed Consultancy Ltd 

IMed Consultancy Ltd provides services related to EU regulations, including EU MDR, EU IVDR, ISO 13485, MDSAP, and UKRP.

UNITED KINGDOM

Lean Entries

Digital regulatory tool ‘Entries’ to navigate the MDR & IVDR principles for instant actionable regulatory knowledge and produce a draft Regulatory Strategy, in minutes. Training and workshops.

FINLAND

Sertika, UAB

Sertika offers services related to EU regulations, including determining EU law safety requirements for your product, conducting gap analyses of technical files, performing internal audits of 13485 or other management systems, and representing clients during NB audits.

LITHUANIA

SQR Consulting

SQR provides consulting services related to compliance with EU medical devices to manufacturers worldwide, focusing on medical device design, risk management, and clinical evaluation.

BRASIL