We help companies & organizations in the medical field (medical device, biotech, pharma, etc.) navigate the world of quality assurance & compliance to achieve their vision, create a significant positive impact on their business growth & expansion, and improve their customers & patients' lives. 

We believe in working together with our clients to find right, tailormade solutions for each of them. Solutions that not only adhere to the industry standards & regulations, but will also support, advance, and help the business achieve better results, and all that without compromising on quality.  

With over 25 years working with leading medium & large international companies and organizations, we understand your company’s requirements, needs, and challenges, on the one hand, and the industry’s standards and regulations on the other hand.

We have significant experience in preparing and managing FDA inspections, Notified Body audits for ISO-13485/CE/MDSAP, ANVISA and INMETRO (Brazil) audits, CSA/UL inspections as well as planning and executing all QMS elements: quality planning, production and process controls, supplier management, product development & design controls, risk management, management reviews, post-market surveillance, internal auditing, verification & validation, CAPA program management, and regulatory strategy for registering devices in the main regions: US, EU, Japan, China and LATAM.

Our services include:
Training & speaking - 
About the various rules & regulations and how to comply with them, by providing training related to Medical Device Quality and Regulatory aspects.

Auditing -
Performing mock audits, internal and supplier audits, and getting you prepared for regulatory bodies inspections

Coaching & Mentoring 
Helping QA personnel to develop professional expertise

Developing & delivering Women Leadership Programs 

Consulting 
Strategic quality planning & execution 
Tailoring the Quality Management System to fit organizations

HD Quality & Coaching Services

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