The company Med Quality held a webinar on the topic: “Assessment of Conformity for Rehabilitation Aids: From Quality System to Registration with the State Service of Ukraine on Medicines”
During the webinar, the company head Vladyslav Kasianenko addressed the following questions:
- Why are prostheses, orthoses, insoles, and custom orthopedic footwear considered medical devices?
- What regulatory requirements apply to custom-made medical devices?
- What are the requirements for manufacturers of prostheses, orthoses, and other rehabilitation aids?
- What needs to be done in addition to registering the medical device in the State Service Register?
- Why should you implement a quality management system according to ISO 13485 at your company? Requirements of Technical Regulation No. 753?
- What is technical documentation for a medical device and what should it include?
Vladyslav Kasianenko is the head of Med Quality. He has conducted over 200 audits, helped more than 30 companies enter the Ukrainian market, and conducted over 40 training sessions on medical device regulation.
The webinar video is available via this link, Vladyslav’s presentation is available via this link.
On our website, the Training Events Plan for August 2024 is posted. We invite you to review and participate in upcoming events.
Have any questions? Write to us at info@medquality.com.ua or call us or write to us via your preferred messenger (Viber, Telegram, WhatsApp):
+38 095 557 37 37
