How to choose the right suppliers, service providers and sub-tier suppliers, and how to monitor them to ensure FDA compliance.
Managing your Medical Device suppliers – Tips for ensuring they are truly FDA compliant
Read this article and find out more on how a Document Control System may help companies to ensure regulatory compliance.
Why my electronic “Document Control System” may only be a “Document Management System”
Software that enables medical device companies to continuously analyze and improve the efficiency of operations through a single solution.
The several factors that must be considered when determining the appropriate sample size for process validation.
Process Validation: How many sample sizes do I need?
The importance of the "risk based approach" for the correct performance and adequate safety of medical devices.
How will ISO 13485:2016 impact your relationship with suppliers?
The key clauses of ISO 13485 and the business benefits of quality management in the medical devices industry.