ISO 13485 Consulting
Our experienced ISO 13485 consultants know these standards inside and out.
We’ve worked with hundreds of equipment manufacturers and developers to evaluate current procedures, this is known as Gap Analysis. Once we’ve determined what gaps exist, we write and implement the appropriate procedures to assure your compliance to the ISO 13485 standard.
Our documentation is clearly written so that you can take “ownership” of these procedures, while also adhering to a format preferred by the registrars.
We can also provide expertise in obtaining CE MARK for Canadian distribution.
With our expertise, you can instill more confidence in your products and services. When you meet ISO 13485 standards, you’re confirming your commitment to the safety and welfare of patients everywhere.
ISO Training and Education
We provide intensive training involving your entire staff ensuring that everyone understands their role throughout all stages. This includes the initial audit, implementation, certification, and ongoing quality control. It’s important to us that you maintain the standards we helped you implement, so we give you all the training you need to meet that goal.
Proper development, production, and installation of medical devices is crucial to the healthcare industry. This is important now more than ever. Patients depend on Medical providers to use the best equipment in examinations and surgical treatments. Any company that handles these devices should make ISO 13485 compliance and risk management a priority. We are here for you to help with this important process.
You can trust our ISO 13485 medical device consultants to guide you in the right direction. We believe in making the implementation of ISO standards as hassle-free as possible. Get in touch today to let PQA help you through this process.