Achieve your regulatory goals holistically and economically

Rely on the know-how of experienced QM specialists.

Do the challenges in quality management and product approval still exceed your company’s capabilities?

The countless specifications and laws in medical device development are giving you a headache, you’ve lost track and have no plan on how to get it back under control?

Does your team also lack the necessary knowledge in the area of Quality Management & Regulatory and hardly have time to acquire the knowledge in day-to-day business?

Is the next audit for EN ISO 13485 on the horizon and is your entire company upside down because of it?

You secretly know that not everything is running smoothly between the departments involved in QM, but you are unsure where processes or communication need to be improved?

You have realized that regulatory goals can only be achieved with the commitment of the entire company and are not a task just for the QM department – but you are unable to implement this realization in practice?

At 3R LifeScience, we ensure that you regain control of the growing regulatory and legal complexity in your company.

With us, quality management becomes a profit guarantor instead of a cost driver

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You want all departments involved in QM to communicate and work effectively with each other to contribute to the company’s success.

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You want to face the next EN ISO 13485 audit calmly because the infrastructure, procedures and methods are perfectly in place and documented.

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You want assurance that your products will always meet current regulatory requirements so they can be brought to market profitably.

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You want to establish clear QM processes and structures in your company so that the next change in legislation does not throw the entire company off track again.

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They want to bring together business and regulatory strategies so that all functional units in the company are working toward a common goal.

Trust in the wealth of experience of our QM experts and help your quality management to new strength.

QM system according to EN ISO 13485

The current version of EN ISO 13485:2016 calls even more strongly than before for a risk-based approach to the development, production, distribution and tracking of medical devices.

Your way to certification according to EN ISO 13485

We create and optimize the appropriate infrastructure with you, document procedures and methods. We evaluate the results of statistics, audits and monitoring measures and ensure the further development of the QM system based on the applicable standards and regulatory requirements.

This way, you are perfectly prepared for the next audit and reduce your QM overhead at the same time.

Key aspects of certification according to EN ISO 13485
  • Creation of relevant documents for design and development processes as well as the corresponding product files
  • Ensuring documentation of change control measures for product or process changes
    Integration of processes for continuous improvement and correction (CAPA)
  • Definition of all processes for which you have responsibility as a manufacturer and marketer
  • Review of your processes outsourced to suppliers and service providers
  • Review of your post-marketing surveillance and vigilance processes
  • Establishment of processes for customer and complaint management
  • Establishment of plans for the maintenance of technical documentation
  • Review of conformity assessments according to MDR
  • Internal auditing of your company to ensure a functioning QM system
  • Preparation and conversion to the MDSAP (Medical Device Single Audit Program)

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:

Pulsion Logo
Berlin Heart Logo
Life Systems Logo
Getinge Logo

Case Studies

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.”

Sven-René Friedel
General Manager,
Berlin Heart GmbH

“We understand that MDR changes a lot of things for you and raises a lot of questions.”

Together with one of our experts, you clarify your requirements and questions. If cooperation is possible, we will arrange a workshop with you.

If you already have clarity about your project requirements and now need support as soon as possible, do not hesitate to call us.