Dear All
We are implementing ISO 13485 and also planning to go MDD. We are into Product development of Radiology & Radiotherapy equipments. Can someone share any template for Product Plan and checklist . To my knowledge following are some of the activities to be covered. I am looking for any templates for the following stages.
1. Project(Requirements, related standards, criteria for product acceptance etc.,
2. Design Requirement Specification , containing topics like Requirement ,specificatoin , Arch, possible options, Verfication , Validation risk Management.
3. Good Project Plan for Medical Device Product development (MDD & FDA).
Thank you,
Valli
We are implementing ISO 13485 and also planning to go MDD. We are into Product development of Radiology & Radiotherapy equipments. Can someone share any template for Product Plan and checklist . To my knowledge following are some of the activities to be covered. I am looking for any templates for the following stages.
1. Project(Requirements, related standards, criteria for product acceptance etc.,
2. Design Requirement Specification , containing topics like Requirement ,specificatoin , Arch, possible options, Verfication , Validation risk Management.
3. Good Project Plan for Medical Device Product development (MDD & FDA).
Thank you,
Valli