MDSAP is one of the (too) few harmonization program among different regulation systems.
If you are looking to expand your market and apply for the WHO prequalification of diagnostics program, you may wonder what are your option and how to proceed.
Are you a CEO looking to expand your business in Korea? Are you a regulatory affair manager and the marketing.
We provide expertise in auditing that can drive change and improvements more effectively.
How to Get The CMDCAS Approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.
The European Community has formally adopted several Directives that apply to Medical Devices. This means that any company.
In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.
What will you learn during this Software Development Life Cycle training class.
What will you learn during this Risk management training ISO 14971 class.
ISO 9001 – Quality management systems requirements, has been updated to revision 2015. The following changes have occurred.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development.