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
2 AM Health
2 AM Health provides EU-regulation related services:
– Consulting and hands-on support in CE certification of class 1,2,3 medical devices and IVD.
– Market access support in the UK, Switzerland, all EU- and more than 60 countries worldwide.
LITHUANIA
8foldGovernance
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.
UNITED KINGDOM
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.
SPAIN
AKRA TEAM
AKRA TEAM is a highly specialized consultancy supporting various stakeholders to bring medical device, in-vitro diagnostic and combination device products to market in a timely manner and in line with complex legal obligations.
GERMANY
be-on-Quality GmbH
be-on-Quality GmbH provides EU-regulation related services: ISO13485, 2017/745 MDR, 2017/746 IVDR, US FDA software, Electrical safety, EMC, Clincial evaluation, MDSW, SAMD, Biological evaluations.
GERMANY
BIOMAPAS
BIOMAPAS serves as a comprehensive outsourcing solution provider to the global life science sector. As a strategic partner for biopharmaceutical and medical device companies, BIOMAPAS offers comprehensive clinical research services across high recruiting countries.
LITHUANIA
Complear
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
PORTUGAL
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.
FRANCE
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).
UNITED KINGDOM
HQ Vector
HQ Vector specializes in quality management and regulatory compliance, focusing on digital technology integration and sustainable growth strategies.
BELGIUM
IMed Consultancy Ltd
IMed Consultancy Ltd provides services related to EU regulations, including EU MDR, EU IVDR, ISO 13485, MDSAP, and UKRP.
UNITED KINGDOM
Labquality
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.
FINLAND
Lean Entries
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
MD101
MD101 assists medical device companies in developing and bringing products to market, accelerating time to market, and ensuring compliance with regulatory standards.
FRANCE
MDR Regulator
MDR Regulator offers consulting and clinical trial services to help medical device and IVD manufacturers introduce their products into European markets.
POLAND
Meddevo
Meddevo are 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!
GERMANY
QbD Group
QbD Group is a consultancy specializing in pharmaceuticals, biotech, and medical devices, ensuring regulatory compliance and operational optimization through scientific and risk management principles.
BELGIUM
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.
BELGIUM
Regulatory Affairs Professionals Society
RAPS is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health.
USA
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
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.
BELGIUM