Knowledge Seminar “Conformity Assessment of Medical Devices”


Seminar organized by the Chamber Healthcare Committee jointly with Chamber Member Company Cratia Ltd. and the Ukrainian Scientific Institute of Certification.

The agenda of the Knowledge Seminar was the following:

I. Practical aspects of conformity assessment of medical devices, by Nikolay Romanyok, Head of the Chamber Working Group on Healthcare Hardware & Medical Devices Manufacturers, Cratia Ltd., Partner.

1. The authorized representative of a foreign manufacturer in Ukraine, its functions and responsibilities;

2. Rules of appointment an authorized representative;

3. Risks of appointment of a distributor of products by the authorized representative;

4. Conformity assessment procedure of the safest medical products, self-declaring;

5. Selecting procedure, interconnection of the national procedures and practices of the EU;

6. Conformity assessment involving the notified body: 

a.   the optimal procedure choice for your business;

b.   what questions to ask the conformity assessment body before the date of application;

7. Application and documentation;

8. Detailed description of the conformity assessment procedures through comprehensive audit of quality management system;

9. Optimization of costs for conformity assessment;

10. Compliance audits;

11. Costs of conformity assessment;

12. Hidden aspects of the batch conformity assessment procedure.

II. Conformity assessment through the comprehensive audit of the quality management system, by Tetiana Pazerska, Chief Auditor of Conformity Assessment Body "Ukrainian Scientific Institute of Certification".

1. Required documentation;

2. What is the object of the audit (and where to go)?

3. Order of the audit;

4. Terms and costs;

5. The most frequent non-compliance (discrepancies);

6. Questions and answers.