What challenges have you faced in the transition to MDR?
Are you overwhelmed with the vulnerabilities that are revealed in the course of MDR approval in your company?
Is your team frustrated with regulatory requirements and not sure how to implement them?
Are you struggling with significant unplanned delays and cost increases on your development projects?
In view of the complexity and multiplied efforts, are you afraid that you will no longer be able to develop innovations in the future?
At 3R LifeScience, we ensure that you have full control over the development of your products and your company despite MDR.
With us, the MDR is a valuable QM measure
You want to meet the requirements of Medical Device Regulation 2017/745 in time for the May 26, 2021 deadline so you can continue to help patients improve their quality of life with your safe, approved products.
They do not want to see the new medical device regulation as an over-regulating, slowing down waste of time and money, but use it as a valuable QM measure.
You want to improve the processes in your company from product idea to market monitoring in order to be future-proof and successful.
Use the MDR as an opportunity for a sustainable optimization of your product portfolio and your marketing strategy – we will help you to realize it.
We check your “MDR readiness”
From May 26, 2021, all medical devices must undergo a conformity assessment procedure in accordance with MDR 2017/745. Existing products must also meet the requirements of the EU regulations step by step. We review the overall consequences for your product portfolio and work with you on the path to MDR compliance.
Your path to MDR compliance
- We perform GAP analyses and actively accompany you on your way to MDR compliance of your processes and products.
- We analyze where you are on the road to MDR compliance and define necessary corrective actions and coordinate their implementation.
- We review all processes for development, production, placing on the market and follow-up.
- We work with a risk-based approach and integrate risk management aspects into all your processes and product developments.
- We support you in establishing and continuously reviewing measures to ensure process safety.
Key aspects of MDR implementation
- Technical documentation
- Verification and validation
- Sterilization, packaging and labeling
- Clinical evaluation and equivalence assessment (MEDDEV 2.7/1 Rev. 4)
- Post-market clinical follow-up (PMCF)
- PMS and Vigilance
- Supplier Management
- OEM and PLM contracts
MDR compliance at suppliers and external service providers
The MDR explicitly requires documented control over suppliers and service providers (such as packaging, sterilization, warehousing). For this reason, we also independently audit your supplier management to assess process safety and control. We analyze how comprehensive your testing system and the documentation on the supplied raw materials, semi-finished products and services are, and whether MDR conformity can be declared on the basis of this.
Certification outside Europe
We support you, for example, with FDA approval and develop registration strategies for your CE-marked product in selected markets outside the EU.
Through an established network of partners we support your entry into selected international markets. This includes communication with authorities, country representatives and independent local license holders.
From possibility to reality
From requirements management to the development of feasibility studies, functional samples and prototypes to verification, validation, approval and market launch – our specialized project managers are at your disposal for any project phase.
These companies have secured their successful future in MedTech through our collaboration:
Project management development of a class IIb/ III product
The company: Internationally active medical technology company in the field of orthopedic implants and instruments.
The task: Review and set-up of processes for CE marking and product registration of medical devices.
Our work: We evaluated the status quo of processes for CE marking and product registration of class I, IIa, and IIb medical devices and implemented additional processes to ensure that regulatory requirements for conformity assessment of both national and international registrations are met. This involved optimizing Regulatory Affairs’ interfaces with other departments and taking steps to integrate the new processes and structures into the company’s quality management system.
Customer benefits: Targeted measures created structures and processes that enabled our customer to optimize its internal processes for CE marking and improve communication with Notified Bodies and national registration authorities. The sustainability of our measures was confirmed in audits.
Product portfolio recertification and MDR gap analysis
The company: Internationally active medical technology company with resorbable bone substitute materials.
The task: Planning and execution of the recertification of the product portfolio according to the European Directive as well as gap analysis regarding MDR requirements.
Our work: We reviewed the technical documentation for the Class III product portfolio and created a new design dossier as part of the recertification. The new MDR requirements and requirements from technical standards were defined and implemented in consultation with the Notified Body.
The customer benefit: Our client’s product portfolio was recertified on time and within budget. New regulated requirements were reviewed and comprehensive remediation measures were initiated to further improve the documentation of the established product portfolio.
“When words were followed by actions and actions by results, I was more than convinced! Thanks to 3R LifeScience, we were able to successfully complete more than a singular product development and bring a product to market that has a great impact for our patients.
In addition, we were able to do a great deal of groundwork of an organizational nature within the company, from which we will benefit in the long term.”
Berlin Heart GmbH