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John Robinson
  • Fremont, CA
  • United States
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A guide to practical Risk Management - Applying ISO14971 and IEC62304 at Philadelphia, PA

October 3, 2019 at 9am to October 4, 2019 at 6pm
Description:Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices…See More
May 14

Profile Information

Area of Expertise or Interest?
GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
Risk Management
Regulatory Compliances
Corporate Governance
Quality Management
Type of Affiliation?
Industry
Years of Experience in MedTech Field
10

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John Robinson's Blog

How to interpret and use more than just a standard tool-box

Posted on January 23, 2019 at 5:51am 0 Comments

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical…
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eCTD Submissions of IND-NDA to the US FDA, EU and Canada

Posted on January 18, 2019 at 5:16am 0 Comments

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review…

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Effective Technical Writing in the Life Sciences

Posted on January 9, 2019 at 6:44am 0 Comments

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the…

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How the FDA interprets advertising and promotion in principle and in fact

Posted on January 7, 2019 at 7:28am 0 Comments

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…

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At 10:49am on October 31, 2014, FRANK KWABENA said…


Good Day,

How is everything with you, I picked interest on you after going through your short profile and deemed it necessary to write you immediately. I have something very vital to disclose to you, but I found it difficult to express myself here, since it's a public site.Could you please get back to me on:( mr.frankkwabena@yahoo.com.hk ) for the full details.

Have a nice day

Thanks God bless.

Mr Frank.

At 8:52am on August 20, 2014, David Hurley said…

Hello my good friend,

How are you? I have something very vital to disclose to you, but I found it difficult to express myself here, since it's a public site. contact me through my email: david.hurley27@yahoo.com

David Hurley.

 
 
 

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