A series of seminars was funded under the Hong Kong SAR SME Development Fund project supported by the HKSAR government for enhancing the awareness and capability of local medical device industries on ISO13485:2016 implementation.
Late July, HKEIA in collaboration with HKPC, organized a seminar on the importance of traceability in electronic component manufacturing, as required by ISO13485:2016, on the 26th July, 2018, @ HKPC Building, Kowloon Tong, Hong Kong,
The following month, another seminar was jointly organized by Hong Kong Medical & Healthcare Device Industries Association (HKMHDIA), with Hong Kong Productivity Council (HKPC) as the project implementation agent with regards to risk management within supplier controls in the medical device industry.
In both situations, as ISO TC210 WG1/JWG and WG6 representative, our company owner Ee Bin was invited to speak in both seminars through much experience sharing and panel discussion.
” Good Traceability – to win your customer with value adding service in the medical device business”
The seminar covered topics such as:
- Traceability – Why it is important for medical device producer to select firms with appropriate track-and-trace arrangement
- Traceability and Recall Handling – How to avoid a total recall by improving traceability
- Solution Application Sharing
The enhancement of traceability in the manufacturing process help the electronics industry in gaining clients from medical industries and reduce the risk of total recall, and to enhance the ability and upgrade the local electronics industry for entering the smart medical and healthcare device industry focusing on parts and components market.
- How much is enough for supplier controls and traceability?
- What are some ways to do track and trace?
Thereafter there was a healthy discussion on the expectations that the medical device manufacturers had placed on the electronics industry, where they are learning about the need for alignment.
“Risk Assessment for Procurement & Supplier Evaluation”
The focus of the seminar was on “How to Manage your Supplier from Components to Outsourced Process in Risk Based Thinking” during the procurement process and the possible methods for applying the concept of risk while managing suppliers, covering the supplier management process from the risk assessment of the components or outsourced process to the supplier evaluation/re-evaluation process, sharing several case studies that illustrated the supplier management from the requirements and auditing perspective.
There were several intriguing questions that were asked and duly responded:
- Is it needed to go after the supplier of the supplier?
- What if the client insists on certain suppliers that are non-compliant?
- What do look out for during the supplier evaluation process?
- Who actually needs to get certified?
Hope the experience and knowledge benefited the sensor, electronics and medical device industry and essential for them when come across difficulties to be in the medical device industry.
We also made many friends along the way, and understood more about the HK medical device industry. The number is just about the same as in Singapore, for example (about 250+ medical device companies).
Along with attractive government schemes, there is great strength in sensors, electronics, and engineering, with proximity to the Chinese market
And never forgetting the great HK food!
