Impact of the new EU Medical Device Regulation on Class I medical Devices
In 2017, the European Commission (EC) released a new revision of its famous EU Medical Device Regulation (MDR), also known as MEDDEV 2.7/1 rev.4.
Centaur Clinical
Speciality Clinical Operations Solutions for Medical Devices
29 avenue d’Aix,,
13120 Gardanne,
France
Centaur Clinical is a clinical research organisation (CRO) specialising in clinical operations for medical devices and small drug studies.
The company supports medical device manufacturers working in a wide range of therapeutic areas, including cardiovascular disease, oncology, dermatology, neurology, infectious disease, orthopaedics and obesity. It also supports drug studies in areas such as cardiovascular disease, oncology, dermatology, neurology, infectious disease and rare disease.
Centaur Clinical’s team of experts comprise clinical research associates, project managers, medical writers, quality affairs specialists and a clinical director, which all help medical device and drug manufacturers meet the regulatory requirements of the EU and the US.
Centaur Clinical
Worldwide CRO services for medical device development
Centaur Clinical’s cost-efficient CRO services support manufacturers throughout the product’s lifecycle.
The company has a strong network of industry professionals and partnerships worldwide that offer advice and guidance on medical device concepts and prototypes in clinical development. Centaur Clinical focuses on the EU medical device market and its operations are performed either directly or through its partner CROs.
Operational solutions for Class I, Class II and Class III medical devices
Centaur Clinical helps clients overcome regulatory, market access and reimbursement challenges throughout medical device development. It works with a wide range of products to provide customised support in areas such as:
- Preparation of clinical trials
- Training
- Data collection
- Data monitoring
- Data management
- Biostatistics
- Clinical study reports
Management of documentation for medical device registration and auditing
Centaur Clinical provides documentation for medical device regulatory submissions and audits, including investigator brochures (IB), clinical study reports (CSR), clinical evaluation reports (CER), clinical trial protocols, case report forms (CRF), informed consent forms (ICF) documents, instructions for use (IFU), patient diaries, clinical study reports and clinical evaluation reports.
The company also provides health economics and reimbursement processes.
About Centaur Clinical
Since 2016, Centaur has set up partnerships worldwide to provide clients with a more extensive service. The company supports activities such as clinical operations, reimbursement, market access, contract manufacturing organisation (CMO) and preclinical studies.
Based in the South of France, Centaur Clinical provides a customised service to meet clients’ needs and help bring products to market.
Centaur Clinical’s quality policy:
- Aiming for ISO 9001-2015 certification in 2019
- CFR 21 part II
- ICH-GCP and ISO 14155
- Respect of local, national ethics and regulatory.
If you would like further information, please contact Centaur Clinical by making an enquiry using the form on this page.
Impact of EU Medical Device Regulation on Class I Medical Devices
In 2017, the European Commission released a new revision of its renowned EU Medical Device Regulation, or MEDDEV Rev4.
Centaur Clinical
29 avenue d’Aix,
13120 Gardanne
France