Expertise.
MDR Consulting.
Ensure safe and efficient medical devices by implementing the MDR with Entourage consultants.
Competent.
Secure.
Efficient.
Are you facing challenges with MDR?
Our MDR Consulting.
We support you in integrating the comprehensive requirements of the MDR into your processes and complying with all regulatory requirements. Our experts check your existing processes for MDR compliance, identify potential compliance gaps and initiate appropriate measures to rectify them. In addition, we take care of the complete documentation and submission of all necessary regulatory documents and offer internal training to prepare your team for the MDR requirements.
Technical documentation and approval process.
We guide you through the entire MDR approval process and ensure that your technical documentation is complete and compliant with the MDR guidelines. Our service includes the preparation and review of technical documentation, communication with notified bodies, risk management and clinical evaluation in accordance with MDR standards. We also support you in submitting MDR-compliant documents for the approval of your medical devices.
Post-market surveillance and vigilance.
After market launch, we help you to meet the strict post-market surveillance requirements of the MDR. We develop post-market surveillance plans, conduct safety assessments and risk assessments and ensure incident reporting to the competent authorities. With our vigilance measures, we help to ensure the long-term safety of your products and minimize regulatory risks.
Our MDR Consulting Services.
Regulatory compliance.
- Ensuring full compliance with the MDR regulations
- Support in the creation and management of technical documentation
- Implementation of the safety and performance requirements of the MDR
- Compliance with risk management processes and clinical assessments
Technical documentation and UDI.
- Creation and maintenance of technical documentation in accordance with MDR
- Introduction and management of Unique Device Identification (UDI) for each product
- Registration of products in the central EUDAMED database
- Ensuring traceability and reporting obligations
Post-market surveillance (PMS) and vigilance.
- Development of post-market surveillance plans in accordance with MDR
- Systematic monitoring of product safety and performance after market launch
- Support in reporting serious incidents
- Implementation of corrective measures in the event of identified risks or problems
How we can support you with MDR Consulting.
- Regulatory compliance consulting
- Creation and management of technical documentation
- Approval process for medical devices
- Post-market surveillance and vigilance
- MDR training for internal teams
- Clinical evaluation and performance studies
- Quality management system (QMS) implementation
- EUDAMED compliance and registration
- Risk and change management in accordance with MDR
- Preparation and support for audits and inspections
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?
Order 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.
