Medical Device Single Audit Program (MDSAP)

MDSAP is one of the (too) few harmonization program among different regulation systems.

WHO Prequalification Of Diagnostics

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.

South Korea Medical Device Registration

Are you a CEO looking to expand your business in Korea? Are you a regulatory affair manager and the marketing.

Internal Audit

We provide expertise in auditing that can drive change and improvements more effectively.

Canada Medical Device Registration

How to Get The CMDCAS Approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.

Europe Medical Device Registration

The European Community has formally adopted several Directives that apply to Medical Devices. This means that any company.

How to Get The FDA Clearance?

In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.

Software Development Life Cycle Training

What will you learn during this Software Development Life Cycle training class.

Risk Management Training

What will you learn during this Risk management training ISO 14971 class.

ISO 9001 And Main Changes Since 2015

ISO 9001 – Quality management systems requirements, has been updated to revision 2015. The following changes have occurred.

ISO 13485 And Main Changes Since 2016

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development.