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John Robinson's Blog (247)

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

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

o The US FDA

o European Medicines Agency (EMA)

o Good Manufacturing Practices (GMP)

o Good Laboratory Practices (GLP)

o Good Clinical Practices (GCP)

o All the… Continue

Added by John Robinson on June 6, 2016 at 2:33am — No Comments

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