Medical and Dentisry - Improving Health
For too long, there was no management or common certification relating to medical devices and their use in medicine, surgery and dentistry. There was a reliance on specific technical standards but not with the product life cycle. This changed with the EU's and then the UK's medical device and In Vitro Diagnostic (IVD) Regulations and the extension of CE Mark and then UKCA Logo certification.
ISO 13485 is the internationally recognised standard for a Quality Management System (QMS) specific to the medical device industry. Additionally there are Good Manufacturing Practice (GMP) that complement Clause 7 of ISO 13485 and Good Distribution Practice (GDP) to ensure the integrity of the device from the factory gate to the patient.
Take Action
Ensure quality, safety, and compliance in healthcare and medical operations. Get ISO certified now to enhance patient trust, streamline processes and maintain the highest standards. Contact us if you would like help and support to take the next step.
How Can We Assist?
Please contact us about management Standards, certifications or issues and one of our consultants will be happy to assist you.