Our medical device quality management system services include: ISO 13485, ISO 9001 and MDSAP. As a company with experience in the medical industry, we understand the critical importance of high quality and safety standards in medical device manufacturing. We proudly support our customers in meeting stringent industry requirements such as ISO 13485, ISO 9001 and MDSAP.
ISO 13485: Quality management system for medical devices
ISO 13485 is an international standard that specifies the requirements for quality management systems (QMS) for medical devices. Certification to ISO 13485 helps companies ensure that their products meet both customer requirements and applicable legislation.
ISO 13485 Key Requirements:
- Risk management in the product life cycle.
- Control of documentation and records.
- Design and development processes.
- Control of production and service provision.
- Dealing with complaints and incidents.
ISO 9001: the universal quality management system
ISO 9001 is a globally recognised quality management standard used in various industries. In the context of medical devices, its implementation helps to optimise production processes, improve efficiency and customer satisfaction.
MDSAP: International Medical Device Audit Programme
MDSAP (Medical Device Single Audit Program) enables a single audit that meets the regulatory requirements of multiple jurisdictions, including the US, Canada, Japan, Brazil and Australia. This allows companies to significantly simplify the audit process and increase the
