ISO 13485 Medical Device Consultants

ISO 13485 Medical Devices

ISO Medical Device Consulting

The experienced ISO 13485 medical device consultants at PQA know these standards inside and out.

We’ve worked with 100’s of equipment manufacturers and developers to evaluate current procedures, (Gap Analysis).  Once we’ve determined what gaps exist, PQA will 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.  

Pinnacle Quality Assurance can also provide expertise in attaining CE MARK for Canadian distribution. 

With PQA’s 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.  

ISO Training and Education 

PQA  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. Patients depend on Medical providers to use the best equipment in examinations and surgical treatments, so any company that handles these devices should make ISO 13485 risk management a priority. Pinnacle Quality Assurance can help with this important process.

You can trust your ISO 13485 medical device consultant at Pinnacle Quality Assurance to guide you in the right direction. PQA believes in making the implementation of ISO standards as hassle-free as possible. Get in touch today to let PQA help you through this process.