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 learn the 3 key elements which need to be considered during Advanced Product Quality Planning.
Robust APQP – 3 Keys to Long Term Manufacturing Success
How to select and manage external providers (processes, products and services) taking into account performance and risk-based thinking.
How to control externally provided processes, products and services
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.
Strategizing, road mapping and executing the product line
How this approach is both practical and robust, helping managers tackle the large value proposition.
Overcoming portfolio inertia and portfolio entropy
The seven common mistakes and the best practices for integrating processes.