Multi-Geography Legal Manufacturer

[pankajitkaushik]

My client wants us (our company) to become the legal manufacturer of software medical devices and he (The client) will hold the IP and distributorship. It would be helpful if you shed light on various options available to support my customer requirements and avoid product liability for my company.
The client wants us to support in Multi-Geography including the US, Europe, APAC, Japan, and Australia. Please shed light on the various certifications and standards we need to follow.

 

[shimonv]

Hi pankajitkaushik,
If you should become the legal manufacturer you are liable for the software as a medical product in all the markets you mentioned. Furthermore, you will be responsible for regulatory submissions and post-market requirements and subject the regulatory inspection.

You need to make a strategic decision whether you want to be a legal manufacturer or contract developer. legal manufacturer has its business advantages but it comes with liability and a host of regulatory burdens.

Shimon

 

[pankajitkaushik]

Hi pankajitkaushik,
If you should become the legal manufacturer you are liable for the software as a medical product in all the markets you mentioned. Furthermore, you will be responsible for regulatory submissions and post-market requirements and subject the regulatory inspection.

You need to make a strategic decision whether you want to be a legal manufacturer or contract developer. legal manufacturer has its business advantages but it comes with liability and a host of regulatory burdens.

Shimon

Hi Shimon,

Thanks for the reply, can you pls shed some light on liabilities (Risks) and R Burdens? We already have ISO13485, ISO 9001, ISO 27001, HIPAA

 

[shimonv]

Well, here are some of the major things in a nutshell...
1. You will have to identify country specific regulatory requirements (e.g. registration and labeling requirements) and applicable standards (e.g. IEC 62304, ISO 14971) and follow them.
2. You will need to build a regulatory submission file for each of the target markets, and support the review process until completion.
3. Post-market activities: complaints handling, adverse event reporting, recall (in needed), notification on design changes, post-market surveillance.
4. In the EU you will need to establish relationship with a Notified Body who will inspect your company on product records on an annual basis. It's much tougher and more expensive than local ISO certification.

Not sure that this helps you because it a very broad topic. You will probably need to build a plan with costs and time estimates before your management can make a decision.

Shimon