Develop MDR-compliant medical devices smoothly and efficiently
Get a well-coordinated team from medical technology, regulatory affairs and management on board.
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 ensured their successful future in the MedTech world through our cooperation:
Project management development of a class IIb/ III product
The company: Internationally active MedTech 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 MedTech 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