MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

All Blog Posts Tagged 'development' (16)

It is important and necessary to document Software for FDA Submissions

It is important and necessary to document Software for FDA Submissions2 Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team…


Added by John Robinson on August 7, 2017 at 6:17am — No Comments

All about biosimilars –from development to registration


Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…


Added by John Robinson on June 27, 2017 at 6:01am — No Comments

Meeting equipment validation requirements from the FDA and EU

Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.

The purpose of this equipment validation program is to ensure these…


Added by Compliance4all on May 26, 2017 at 6:21am — No Comments

Marketing and promotion of drugs and medical devices


Added by John Robinson on May 16, 2017 at 6:22am — No Comments

Wrong hiring and ways of avoiding it

A perfect hire is a boon to any organization. At the other extreme, a bad hire can bring the inverse result to the organization: It can not only impede productivity; it can even result in drawing the organization into legal issues associated with wrong hiring. Problem employees create employee problems, which is why HR professionals need to be aware of what steps to take and what scenarios to avoid if…


Added by John Robinson on May 5, 2017 at 6:21am — No Comments

Validation in accordance with ICH guidelines


Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH…


Added by John Robinson on May 3, 2017 at 6:18am — No Comments

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major…


Added by Compliance4all on April 19, 2017 at 6:44am — No Comments

A look into the 21st Century Cures Act

Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…


Added by Compliance4all on March 16, 2017 at 6:00am — No Comments

Digital Healthcare in the UK

The constant pressure on health services is an age old cliche, we need to constantly look at ways of improving the method of delivery with the growing demand of patients. We believe that everyone in the world should have access to safe, fast, affordable healthcare. Yet our healthcare services are falling short. Technology that connects patients with high quality care is part of the solution and we think we’re uniquely positioned to build it.

This correlates with the latest…


Added by Dr Felix on March 13, 2016 at 8:18am — No Comments

New Books ... Recommended Reading From MedTech-IQ!


In the continuing quest to bring you the 3C's of "Content, Community & Collaboration" please see our latest list of recommended books.

For your convenience, you can order a selection directly, if you choose, thru The "MedTech-IQ" Recommended Reading Center carousel. The book carousel is located on the "MedTech-IQ" homepage, just under "Latest… Continue

Added by CC-Conrad Clyburn-MedForeSight on September 17, 2009 at 10:30am — No Comments

Infrastructure Rock Stars - April 28th - The Historic Pennsylvania Infrastructure Summit

The Historic Pennsylvania Infrastructure Summit

April 28, 2009, Harrisburg Hilton

(Harrisburg, PA) - - Through the efforts of many Infrastructure Group members the 2009 Summit offers industry-leading presentations, including:

Kim Prizzingrilli, Commissioner, Public Utilities Commission

Joseph Markosek, Chairman, House Transportation Committee

Allen Biehler, Secretary, PA Department of Transportation

Rob Wonderling, Chairman, PA Senate… Continue

Added by Kelly Lewis on April 5, 2009 at 11:50pm — No Comments

New Member Update ... 20 March 2009


Since our last update, the MedTechIQ community has grown by 50 members, now exceeding over 500 international medical technology experts. This is great. We are glad that the community is growing, and hope you find the network useful. That said, it is not about the numbers alone. We are endeavoring to build on the 3C's of "Content, Community & Collaboration". So, fill out your Member profiles, join the MedTechIQ specialty groups of your interest, and share your… Continue

Added by CC-Conrad Clyburn-MedForeSight on March 20, 2009 at 9:49pm — No Comments

New Member Update & Joyful Christmas, Hanukkah, Kwanzaa & Eid Season (Part 1)

A message to all members of MedTechIQ


December is a joyous time for people of all faiths...Happy Holidays all!

In the spirit of the season, lets welcome these new members of the MedTechIQ community...


Babs Soller: Patient monitoring, near infrared spectroscopy, tissue perfusion

David Devore: R&D management, including industrial and academic virtual network organizations; polymer, colloid… Continue

Added by CC-Conrad Clyburn-MedForeSight on December 24, 2008 at 6:30am — No Comments

New Member Update - Part 4

A message to all members of MedTechIQ


There have been a rash of new members joining MedTechIQ. And now, New Members not previously noted (if we have missed you, we will get you on the next update):


Bob Waddington: Interactive Media, Simulation, Serious Games, ADL. USA

Phillip Singerman: Tech… Continue

Added by CC-Conrad Clyburn-MedForeSight on December 2, 2008 at 4:30pm — No Comments

Mike Russell's (@planetrussell) Feed

Added by Michael J. Russell on October 8, 2008 at 11:30am — No Comments

Who are the Technology Rich States - in the US?

The Milken Institute State Technology and Science Index, which ranks states based on their technology and science capacity to contribute to economic development, placed: 1) Massachusetts, 2) Maryland, 3) Colorado, 4) California, 5) Washington, 6) Virginia, 7) Connecticut, 8) Utah, 9) New Hampshire, 10) Rhode Island.

Added by CC-Conrad Clyburn-MedForeSight on July 9, 2008 at 9:00am — No Comments

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