Quality | Compliance | Regulatory
FDA and EU Compliance
With the ongoing changes of the regulations and standards requirements in the US, Europe and other countries, you need a strong, well-versed compliance expert to help you interpret and easily reflect those changes in your Medical Device Quality System. Thus, to increase your product efficacy and safety
Quality System certification
Strategizing and structuring a company's agile and compliant quality system is a form of art. It requires vast knowledge not only of the relevant regulations and standards but overall understanding and experience in medical device product design, manufacturing and purchasing control deep processes.
Audit Management & support
A compliant, solid quality system requires active and periodic auditing and maintenance. Suppliers controls and Audit management are a big part of the success of a living and breathing quality system. By partnering with critical suppliers we help you achieve higher product and process quality
THE HENDERSON QUALITY COMPLIANCE WAY
Expert Guidance
As a professional medical device quality and compliance Consultant, I am committed to providing solutions that are tailored to each clients unique circumstances. From making improvements to implement proven best practices to responding to supply chain disruptions, we're here to guide you through any and all processes. With our help, you will transform your plans in no time. Take a look around my site and get in touch to schedule a conversation.