DEKRA Medical Services
Medical Device Legislation
As new technologies emerge in the healthcare industry, patient safety remains a number one priority. Organizations will need to hire new talent and/or work with organizations that have the right skill set for this dynamic, ever-changing industry. DEKRA provides you with the expertise for testing and certification services in the healthcare and medical devices industry.
The safety and quality of medical devices is becoming increasingly important as the healthcare industry prepares to enter the next decade. Firstly, consumers are demanding the highest safety standards from suppliers of products and services in the healthcare sector. Secondly, international rules and regulations for medical device manufacturers are becoming increasingly complex and stringent as devices become more innovative, but also more prone to privacy issues, security threats, and health risks.
ISO 13485 is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for medical device manufacturers.
Notified-body medical device certification for in-vitro diagnostic products according to regulatory requirements mandated by European and international norms.
Regulatory certification for medical devices subject to the strictest quality, reliability and safety compliance standards to protect public and private health.
Program designed to efficiently provide medical device manufacturers a single audit report and certification recognized across several regulatory jurisdictions.
UKCA marking will replace CE-marking in Great Britain. DEKRA is in the process to become a UK Approved Body for medical certification.