20 September 2019
In collaboration Hong Kong Standards and Testing Centre and LC&P Ltd., the seminar on "Managing Regulatory Submission Pitfalls and Ways to Avoid Them: A Practical Perspective" was successfully held on 20 September 2019.
This seminar aimed to address the most critical pitfalls in regulatory submission and advise ways to avoid them. It offered a variety of sessions covering the latest regulation, quality assurance and testing standards of the medical device industry.
Welcome speech by Dr. Franki Lee of STC
Presentation on "The common non-compliances encountered in clinical evaluation" by Mr. Eric Leung of LC&P Ltd.
Presentation on IEC 60601-1 by Ms. Vena Zhuang of STC
Presentation on ISO 10993-1:2018 by Mr. Jonathan Tang of STC
Presentation on MDR by Mr Lane Ji of BSI China
Presentation on the advantage of using 3rd party local representative by Mr. Paul Chan of LC&P Ltd.
Group photo of speakers and staff