Expertise.
MDR Consulting Services.
Ensure safe and efficient medical devices by implementing the MDR with Entourage consultants.
Ready.
Be fit for compliance and classification.
Efficient.
Bring all business units together.
Optimal.
Create overview, transparency and productivity.
MDR Consulting Services needed?
How we support you with MDR Consulting Services.
- Identification of the new requirements for your products (e.g. through reclassification)
- Strategic advice on a roadmap for the compliance of your products after MDE
- Support with labelling and introduction/maintenance of the UDI
- Planning and preparation of approval documentation
- Supply
- Support a strategic plan for the submission of dossiers under MDR
- Maintenance of product dossiers for sustainable compliance
- Intensive stocktaking and analyses at different levels of depth
- Identification of pain points
- Creation of a strategy to close gaps quickly
- Documentation control and creation over the life cycle of your products from design to production and approval, to post-market surveillance and post-market clinical follow-up (PMCF).
- Risk-based assurance of the quality of your products with the help of pragmatic and individual solutions
- Validation and qualification of your processes and systems
- Strategic planning of clinical investigations and clinical follow-up, tailored to your product class
- Preparation and support of the clinical documentation required under MDR
MDR Consulting Services needed?
Book our QuickCheck now.
With the introduction of the Medical Device Regulation 2017/745 in May 2021, approval of medical devices under the MDD (93/42/EEC) will finally no longer be possible. The new EU MDR 2017/745 regulation, with its 123 articles, 10 chapters and 17 annexes, represents a fundamental revision of the European regulatory framework aimed at ensuring the quality and safety of medical devices manufactured or supplied in Europe. The new set of requirements includes a tightening of existing rules and criteria, a broader definition of a medical device and the introduction of economic operators as an objective of the new regulation.
The changes to the current Medical Devices Directive can be seen as a mere revision, but should be seen as a completely new piece of legislation that will come into force in May 2021 and will be relevant to any company looking to manufacture or supply MD in Europe - from start-up companies looking to reduce time to market to established organisations looking to ensure business continuity and manage the transition period effectively.
Understand the new requirements.
A thorough understanding of the requirements of the new Medical Device Regulation is key to manufacturing and selling certified medical devices in markets around the world.
Entourage supports you as an experienced partner.
Check and act. MDR Consulting Services with Entourage.
Embrace the new regulatory compliance goals - such as full device traceability, tighter pre-market controls, transparency, UDI, and clinical evaluation - perform a successful GAP analysis, review your technical documentation, and register your product for long-term success.
Become a part of the team.
Entourage is looking for life science professionals.
