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Helit Dovrin - HD Quality & Audit Services

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, tailor-made 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 

  • Auditing 

  • Coaching & Mentoring 

  • Developing & delivering Women Leadership Programs  

  • Consulting

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  • Medical Device Design Controls For Engineers - Online Live Training (Hebrew)
    Medical Device Design Controls For Engineers - Online Live Training (Hebrew)
    Mon, 27 May
    Virtual Event
    27 May 2024, 9:30 am – 1:00 pm GMT+3
    Virtual Event
    27 May 2024, 9:30 am – 1:00 pm GMT+3
    Virtual Event
    Design Engineers and Product/Project Managers are welcome to join a basic training on Medical Device Design Controls and their implementation according to ISO-13485 and applicable regulations such as US FDA QSR (21 CFR 820). What each Design Controls element requires? Join me for half-a-day training
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