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John Robinson
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  • Fremont, CA
  • United States
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Handheld Medical Devices - The Next Revolution in Healthcare?
1 Reply

IntroductionHandheld devices are light-weight and compact devices that can be operated holding it in your hands. Handheld medical devices are available for medical information, used by physicians,…Continue

Tags: device, healthcare, fda, training, devices

Started this discussion. Last reply by Arnold Brame Aug 16, 2014.

 

John Robinson's Page

Latest Activity

John Robinson posted events
Mar 10
John Robinson posted events
Feb 21
John Robinson posted events
Feb 20
John Robinson posted a blog post

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

 Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full…See More
Feb 15
John Robinson posted a blog post

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory body, the Medical Device…See More
Feb 13
John Robinson posted a blog post

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k)…See More
Feb 10
John Robinson posted blog posts
Feb 7
John Robinson posted a blog post

Quality is everything for a product or service

Quality is everything for a product or service. Quality is defined in different ways. One of the well-known definitions of Quality is the ability of a product or service to reach expected levels of excellence. This is a simple theoretical definition. In practice, though, Quality is a highly painstaking area of activity that is necessary across all functions of all industries. If a product does not meet its quality requirements or criteria, it is doomed to failure.An organization can understand…See More
Feb 3
John Robinson posted events
Feb 3
John Robinson posted an event
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Singapore Seminar on Pharmaceutical Water Systems 2017 at Mandarin Orchard Singapore

April 6, 2017 at 9am to April 7, 2017 at 6pm
Overview:This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential…See More
Feb 2
John Robinson posted blog posts
Feb 1
John Robinson posted events
Jan 31
John Robinson posted a blog post

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn't this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the…See More
Jan 25
John Robinson posted a blog post

Management for Medical Device Industry

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20…See More
Jan 23
John Robinson posted a blog post

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by…See More
Jan 20
John Robinson posted blog posts
Jan 17

Profile Information

Where do you live (city, state, country)?
Fremont
What industry do you work in?
Pharma
What is your job title?
Event Coordinator
What company do you work for or associate with?
GlobalCompliancePanel
Do you currently use or recommend Personal Protective Equipment?
Not Sure
How did you find our online community?
Through Google
What best describes the role you play in the purchase of safety products?
Specify what hand protection to purchase

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John Robinson's Blog

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

 

Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC…

Continue

Posted on February 15, 2017 at 6:24am

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory…

Continue

Posted on February 13, 2017 at 7:29am

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and…

Continue

Posted on February 10, 2017 at 4:20am

Applied statistics for scientists and engineers

Posted on February 7, 2017 at 6:20am

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At 4:23pm on February 9, 2012, Ken Oswald said…
Welcome to the community. I hope you find it is a wonderful resource full of information through our blogs, networks, forums and groups. Again welcome.

Ken O
 
 
 

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Latest Activity

Adam Fleaming posted a blog post

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?This is simply not the case. Quality and compliance are built into a medical device…See More
3 hours ago
Scott Effinger is now a member of Online Safety Community
17 hours ago
Adam Fleaming posted a blog post

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither…See More
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Adam Fleaming posted events
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Forum

OSHA 500 and 510 9 Replies

Hey Guys,How many of you have taken the 510 and 500 OSHA Trainer course? I am thinking about taking these 2 classes and become an OSHA trainer for my company. What are your guys thoughts on the…Continue

Started by Alfred Good. Last reply by Mymic Mar 15.

OSHA Training, Standards & Best Practices 3 Replies

Get trained on OSHA regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best…Continue

Tags: Webinar, Training, 2011, OSHA, compliance

Started by admin. Last reply by Mymic Mar 15.

FORKLIFT TRAINING CLASSES 21 Replies

Any ideas on how to make Forklift Training Classes more interesting and fun?

Started by Marcia Whatley. Last reply by Mymic Mar 15.

Our Safety in Their Hands 16 Replies

This thought provoking workplace safety infographic features the top 5 organizations that have made the biggest impact on occupational health and safety. It features the U.S governments OSHA,…Continue

Started by Lorenzo Miguel. Last reply by Mymic Mar 15.

OSHA Training on the GHS Labeling System 3 Replies

Anyone wanting to get educated about the new OSHA training requirements on GHS labeling systems should view the free online tutorial at…Continue

Tags: hazcom, 1910.1200, labeling., training, osha

Started by Curtis Chambers, CSP. Last reply by Mymic Mar 15.

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