New Consultation Guidelines from Center of Medical Device Evaluation (CMDE)
The Center of Medical Device Evaluation (CDE) released […]
New Consultation Guidelines from Center of Medical Device Evaluation (CMDE) Read More »
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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 dra
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
Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation
It’s Ready for Publication! Finally, the long-awa
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ISO13485 Revision Reaches The Final Stage
Revision development of the International Standard ISO1
ISO13485 Revision Reaches The Final Stage Read More »
Of Hopes And Dreams
A newbie’s view of a healthcare entrepreneur̵
Of Hopes And Dreams Read More »
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
Learning Process Validation through Human Relationships
I remember with fondness of my late mother chatting wit
Learning Process Validation through Human Relationships Read More »