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John Robinson's Blog (25)

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines…

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Added by John Robinson on April 26, 2017 at 8:06am — No Comments

Article on “Statistical Sampling Plans for Medical Devices”

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Added by John Robinson on April 21, 2017 at 6:04am — No Comments

Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

Overview:

Why Should You Attend?

By attending, you will take advantage of a great opportunity to advance as a manager to the next level!

Too often, we focus on getting things done and…

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Added by John Robinson on April 20, 2017 at 7:20am — No Comments

Rising in one’s career through leadership management

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Added by John Robinson on April 19, 2017 at 5:09am — No Comments

FDA and EU requirements on data integrity and implementation

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Added by John Robinson on April 17, 2017 at 5:49am — No Comments

Applied Statistics for FDA Process Validation 2017

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Added by John Robinson on April 12, 2017 at 5:30am — No Comments

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…

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Added by John Robinson on February 15, 2017 at 6:24am — No Comments

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…

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Added by John Robinson on February 13, 2017 at 7:29am — No Comments

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…

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Added by John Robinson on February 10, 2017 at 4:19am — No Comments

Applied statistics for scientists and engineers

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Added by John Robinson on February 7, 2017 at 6:23am — No Comments

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

Overview:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance…

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Added by John Robinson on February 1, 2017 at 4:55am — No Comments

Water System Validation in Pharmaceuticals Industry 2017

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…

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Added by John Robinson on January 31, 2017 at 5:09am — No Comments

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…

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Added by John Robinson on January 25, 2017 at 4:59am — No Comments

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…

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Added by John Robinson on January 23, 2017 at 7:46am — No Comments

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…

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Added by John Robinson on January 20, 2017 at 5:50am — No Comments

HIPAA survival needs intimate knowledge of the nuances of the law

HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need…

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Added by John Robinson on January 17, 2017 at 4:32am — No Comments

Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices…

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Added by John Robinson on January 16, 2017 at 5:46am — No Comments

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global…

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Added by John Robinson on January 13, 2017 at 4:54am — No Comments

Regulatory Filing Requirements for medical devices in Japan

Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing…

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Added by John Robinson on January 12, 2017 at 4:51am — No Comments

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