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John Robinson's Blog – January 2017 Archive (12)

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

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the…

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Added by John Robinson on January 11, 2017 at 5:01am — No Comments

HIPAA Security Rule

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health…

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Added by John Robinson on January 10, 2017 at 4:45am — No Comments

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.

Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various…

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Added by John Robinson on January 9, 2017 at 6:00am — No Comments

Software Validation Process for 21 CFR Part 11

Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.

The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various…

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Added by John Robinson on January 6, 2017 at 4:35am — No Comments

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