We are launching the new discussion forum and content resource location for biomedical quality topics at ASQ.
Please briefly introduce yourself and provide input as to the topics that you need more information on, clarification, or have questions about.
What areas are you focused on? What topics or training content can the Biomedical Division myASQ community provide input on?
Forum is intended to provide continued member value - your participation in our peer volunteer group makes it happen.
Thank you for participating and sharing with the community as we try to improve quality in our organizations, products, and activities.
Biomedical Division MyASQ Community Page Admin
How can I help you? I am a Quality and Regulatory leader working in a medical device company with offices in Chicago and Harrisburg PA. Hope to hear from you!
I am a Principle Quality Engineer for an over-the-counter oral care company in Grand Rapids, MI.
What areas are you focused on?
From the ASQ point-of-view, I am passionate about the CBA Exam (Certified Biomedical Auditor)
What topics or training content can the Biomedical Division myASQ community provide input on?
I am all way out looking for the things that I don’t know that I don’t know. The world is an amazing place full of people with different ideas and approaches that I can learn from. I am really looking forward to what this myASQ community can become.
Glad to see this site active. Noticed the focus on medical devices, I hope we are going to discuss combination products and IVDs as well, as these are an important part of many companies activities.
Heavy interest and almost 20 years lecturing and teaching Risk Management, with so many thanks to so many Biomedical Division members for a great career.
Over 40 years in the Medical Device industry and technology, and 33 years member of ASQ, Biomed Division.
Masters in Cardiac Physiology, and Business Administration (Computer Information Systems), and equivalent minors in EE and Chemistry.
ASQ Fellow, CQE, CRE, CQA, CBA, RAC(US), past Chair Biomedical Division.
Hoping to see the Biomedical Division able to change its name to the Medical Device Division - much more identifiable with our industry.
My name is Donna Campbell, I'm currently an assessor for BSI and a long time member of the Biomedical Division.
I look forward to the new changes.
I'm from Buenos Aires, Argentina.
I work as a QA manager in an IVD company. I've been working for 20 years in MD industry focusing on Quality Management System following the standards (and their previous versions) ISO 9001:2015, ISO 13485: 2016, MDR (CE marking) and 21 CFR 820. During these 20 years, I've been working with these standards in MD equipments, Implants and now in IVD.
The topics I'm really interested in are the international regulatory changes coming initially from the CE, the new ISO 13485:2016, their linked standards and their practical application in industry.
Now, I'm focusing on a master course in Quality Engineering that helps me to prepare myself to the CQE exam.
After finishing this course, I would like to help to grow this division in latinoamerica area.
Right now Quality is such an afterthought at my R&D Medical Device startup that I feel like I'm in the back alley with a trenchcoat and dark glasses, offering FDA Guidances to the Engineers. "Psst, buddy . . . Want a *software guidance*?"
So, medical devices, software, documentation