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.
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)