Expertise.
ISO 13485 certification.
Ensure your products are certified securely from start to finish with Consulting from Entourage.
Conform.
Meet global requirements.
Sure.
Increase effectiveness and patient safety.
Quickly.
Accelerate market and product launches.
ISO 13485 certification required?
With hardly any other product does quality have such a direct impact on the efficacy and safety of patients, users and possibly others as with medical devices.
Therefore, many national regulations require manufacturers and suppliers of medical devices to prove that they have a quality management system in place. This quality management system is audited and certified by an independent body.
If manufacturers or suppliers do not have a certified quality management system, it is usually more difficult for their products to be approved in the large, important markets. Delays in market entry and loss of sales can be the result.
Why ISO 13485 certification is important.
In the European Union, the requirements of EN ISO 13485 have been harmonised with the requirements of the EU Medical Devices Directive (93/42/EEC), the In Vitro Diagnostic Medical Devices Directive (98/79/EC) and the Active Implantable Medical Devices Directive (90/385/EEC).
Certification according to EN ISO 13485 by an accredited certification body automatically leads to a presumption of conformity. Accordingly, a manufacturer certified to EN ISO 13485 is presumed to comply with the aspects of the requirements of these directives covered by the standard.
The advantages of ISO 13485 at a glance.
- Certification enables improved access to global markets
- Examinations are described and processes optimised
- Efficiency is increased, costs are reduced and monitoring of supply chain performance is improved.
- The medical devices manufactured are safer and more effective
- Customer expectations and requirements from the directives (MDD, IVDD and AIMD) are met
ISO 13485 certification required?
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Case Studies.
A start-up founded six months ago is developing an IVD product and wants to be certified for DIN EN ISO 13485.
Outcome.
- Suitable notified body selected
- Processes established and put on paper
- Employees trained on new QMS
- Accompanied by internal CAPA audit and first audit
- Sustainable quality culture established that guarantees successful audits in the future
The customer from the medical technology sector had many deviations in the last audit and therefore saw a short-term need to update its quality management system together with Entourage in order to successfully complete the follow-up audit.
Outcome.
- Existing problems analysed and eliminated
- Processes jointly optimised and implemented in the respective departments
- Successfully accompanied through the next audit
Become a part of the team.
Entourage is looking for life science professionals.
How we can support you with ISO 13485 certification.
- Complete preparation for an ISO 13485 audit
- Optimise individual areas of your QMS
- Support in the creation of SOPs and other QMS-relevant systems
- Support with CAPAs
- Validations and qualifications incl. CSV
- Establish risk-based approach and implement risk management
- Supplier management / outsourced processes
- Conducting internal audits and mock audits
