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
You want all departments involved in QM to communicate and work effectively with each other to contribute to the company’s success.
You want to face the next EN ISO 13485 audit calmly because the infrastructure, procedures and methods are perfectly in place and documented.
You want assurance that your products will always meet current regulatory requirements so they can be brought to market profitably.
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.
They want to bring together business and regulatory strategies so that all functional units in the company are working toward a common goal.
QM system according to EN ISO 13485 – your path to certification
The current version of EN ISO 13485:2016 calls for an even stronger risk-based approach to the development, production, distribution and follow-up of medical devices than before.
Together with you, we create and optimise the corresponding infrastructure, 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.
We check your "MDR readiness"
From 26 May 2021, all medical devices must undergo a conformity assessment procedure according to MDR 2017/745. Existing products must also comply with the requirements of the EU regulations step by step. We review the overall consequences for your product portfolio and work out the path to MDR compliance together with you.
Your path to MDR compliance
- We conduct GAP analyses and actively accompany you on your way to MDR compliance of your processes and products.
- We analyse where you are on the path to MDR compliance and define necessary corrective measures 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.
Focal points for MDR implementation
- Re-classification
- Technical documentation
- Verification and validation
- Sterilisation, packaging and labelling
- 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
- UDI
MDR compliance at suppliers and external service providers
The MDR explicitly requires documented control over suppliers and service providers (such as packaging, sterilisation, warehousing). For this reason, we also independently audit your supplier management to assess process safety and control. We analyse 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.
Approval 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 licence holders.
Trust in the wealth of experience of our QM experts and help your quality management to new strength.
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:
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