Management systems
Regardless of where in the world a medical device is intended to be sold, the requirements of the applicable regulatory frameworks must be fulfilled. It is not enough for the manufacturer to initially show that the product is safe – a functioning quality system must also be in place. The quality system shall control the business and ensure a continuous production of safe products. Therefore, the regulatory framework for medical devices includes requirements for quality assurance of both the product and the business.
The basic requirements of the quality system differ somewhat between different markets. In the EU, Canada and Australia for example, the use of standard ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes) is cited. In the United States, the requirements of the quality system are included in the regulatory framework of 21CFR820 (QSR).
Symbioteq has extensive experience in development, implementation and optimization of efficient and effective quality systems that meet the requirements of the ISO-standard as well as the regulations in the EU and the rest of the world. We do not sell a standard solution. For the quality system to function and provide business value, the standard requirements must be adapted to each company’s specific needs and conditions.
Our consultants provide support for companies who have decided to implement a quality management system and are aiming to achieve a certification of their business. This includes, for example:
Business analysis
Review of the requirements of standards and regulations (ISO 13485, QSR, MDD etc.) relevant for the business and an analysis of the current quality system to provide a picture of what will be required for certification.
- Planning and implementation of systems according to ISO 13485, ISO 9001, QSR etc.
- Process mapping
- Internal audits
- Supplier audits
- Education and training
|
