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”
Read this article and find out more about how to prevent the maintenance area from losing its strategic position and to keep it from acting in a purely reactive manner.
Why Maintenance Departments Regress
Read this article and learn the 3 key elements which need to be considered during Advanced Product Quality Planning.
Robust APQP – 3 Keys to Long Term Manufacturing Success
Software that enables medical device companies to continuously analyze and improve the efficiency of operations through a single solution.
SoftExpert offers a software that meets the specific needs of automotive industry in all aspects from managing product lifecycle to performance indicator monitoring, environmental, health and safety management and much more.
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.
ISO 13485 – Medical devices quality management systems
The differences among product line strategies, business strategies and corporate strategies.