What challenges do you face when developing product innovations?
Are you overwhelmed by the increasingly complex requirements in product development?
Do you know all the technical, regulatory and economic aspects of product development, and can you bring them together in a aimed manner?
Are the required competencies in your company available in the specialist departments and are they permanently available?
Does the development of new medical devices threaten the profitability of your company?
At 3R LifeScience, we ensure that you can implement your product ideas efficiently and in compliance with the law, in line with increasing complexity in product development.
With us product development is fun again
Your goal is to develop products as efficiently as possible and in compliance with the law.
You want to avoid delays, cost explosions and other unpleasant surprises in development, verification and approval
You want to sustainably optimize R&D processes throughout the company.
They want to create commercially successful products that are appreciated by patients and users.
You are willing to bring strategic development or technology partners on board to compensate for competence and capacity bottlenecks.
Use the knowledge advantage of experienced medical devices project managers for progress and growth.
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 help you at any project phase.
Research & Product Development
Supply Chain & Production
Quality Management & Regulatory
These companies we have successfully supported:
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