QMS for Medical Device Manufacturers
Implementing and maintaining an effective and compliant quality management system (QMS) in accordance with Medical Device Regulations (EU) 2017/745 is a requirement when applying for or extending certification in Europe.
SAXOCON is an ISO 13485-certified company, so we know what it takes to get certified. Our QMS consultants provide medical device manufacturers with the necessary templates, training, and consultations to achieve compliance. We work with organisations of all sizes, from early start-ups to mature businesses, helping design and maintain effective QMS systems that comply with ISO 13485 and other relevant regulatory requirements.
Why choose us?
SAXOCON services for medical device manufacturers give you access to:
- Tailored solutions based on your need for support
- Personnel with the experience and qualifications to professionally implement and audit your QMS and processes per the ISO 13485 and ISO 14971 standards
- Specialised technical knowledge regarding the biocompatibility aspects of the ISO 10993 series
- A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
Delivery
SAXOCON compiles all necessary documentation to ensure your QMS is compliant.