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 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



8foldGovernance provides EU-regulation related services: EU MDR/IVDR regulatory strategy, EU MDR/IVDR + ISO 13485-compliant QMS implementation and remediation, EU MDR/IVDR technical file creation and review, outsourced PRRC, EUDAMED registration.


A3Z advanced

A3Z advanced provides EU-regulation related services: medical device documentation expert: QMS, product classification, risk management, clinical evaluation, post-market follow-up and clinical Evaluation & investigation: regulatory compliance and monitoring.



Complear offers expertise in Software, providing complete regulatory affairs and quality support services. We also have an eQMS and eTD digital platform to guide and support regulatory compliance



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.


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.


Dr. Alan Crofts 

Dr. Alan Crofts provides EU-regulation related services quality guidance and control (pharmaceuticals and medical devices), regulatory and procedural guidelines, Eu pharma law, health technology appraisals (data synthesis and cost/benefit modeling).


IMed Consultancy Ltd 

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



Labquality provides EU-regulation related services MDR/IVDR regulatory affairs expertise for devices from implants to AI software & in vitro diagnostics. Clinical investigation and performance study design & execution, GDPR & study data management.


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.



With meddevo we’re offering a SaaS that is tailored to the needs of people working in regulatory affairs for medical devices. Automate your Technical Documentation with meddevo and save time!


Qualix BV

Qualix BV provides EU-regulation related services: Quality, clinical and regulatory affairs consulting, with a clear mission to provide high quality, pragmatic and personal advice to successfully market innovative IVD and medical devices.


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.


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.


Verstappen MedTech Consulting BV

Verstappen MedTech Consulting BV provides EU-regulation related services: MDR, IVDR, ISO 13485:2016, resolving compliance issues with regulators, quality Regulatory and HTA advice.