10 Posts
Hello and welcome to the myASQ Biomedical Page...
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.
George Marcel
Biomedical Division MyASQ Community Page Admin
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.
George Marcel
Biomedical Division MyASQ Community Page Admin
8 Replies
4 Posts
This website is really going to help me stay connected to the Division activities!
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!
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!
6 Posts
Hello. Keith Councell here.
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.
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.
9 Posts
I am Edwin Bills, ASQ Fellow, thanks to many friends in the Biomedical Division. Currently consulting and participating in the development of standards, including the new edition of ISO 14971 and its companion guidance ISO TR 24971, as well as an AAMI guidance on Combination Products Risk Management and others. My passion is health products risk management with over 20 years in the subject teaching as well as actively participating as a Director of Risk Management at a medical device company. I do have 31 years in the device industry.
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.
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.
2 Posts
I'm Barry Craner
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.
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.
2 Posts
Hello. My name is Dorian Pearson-Shaver. I am a Quality Specialist for a medical device company in Orlando, FL. I am helping my company build and 21 CFR 820 compliant quality system and in the next year or two I would like to become a CBA.
1 Posts
Hello,
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.
Donna
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.
Donna
8 Posts
Hello everyone.
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.
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.
1 Posts
My name is Andrea; I'm a second career Document Specialist working my way up to being a Quality Specialist.
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
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
