Release for Public Comment – Registration Requirements for Innovative Medical Devices – China FDA
“The Requirements of Application Materials for Special Approval of Innovative Medical Devices (The Draft)”, pu […]
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New Consultation Guidelines from Center of Medical Device Evaluation (CMDE)
The Center of Medical Device Evaluation (CDE) released the draft of the “Guidelines for the Management of Medi
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List of Clinical Trial Exempt Devices – Updated List by China Food and Drug Adminisration (CFDA)
The China Food and Drug Administration released the draft “List of Clinical Trial Exempt Devices – Second List
Access-2-Healthcare Partners with Rob Jelas Regulatory Training & Assistance to Help New Zealand manufacturers Understand ISO13485:2016
“Since New Zealand gets the first rays of sunlight, why not be the first to receive the face-2-face training f
Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation
It’s Ready for Publication! Finally, the long-awaited revision of ISO13485 is approved for publication &
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ISO13485 Revision Reaches The Final Stage
Revision development of the International Standard ISO13485 has reached the final stage, with the voting by th
ISO13485 Revision Reaches The Final Stage 続きを読む »
Of Hopes And Dreams
A newbie’s view of a healthcare entrepreneur’s gathering. I became part of the www.meetup.com comm
Setting the record straight…. what do some terms and phrases mean within the ISO13485 Standard
An opportunity came up to help provide clarity on some of the specifics within ISO13485 during a regional conf
Learning Process Validation through Human Relationships
I remember with fondness of my late mother chatting with me while she was working on her clothes on her Singer
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