All Blog Posts Tagged 'devices' (42)

It is important and necessary to document Software for FDA Submissions

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…

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

Quality Assurance Auditing for FDA-regulated industries

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A…

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Added by John Robinson on July 26, 2017 at 5:52am — No Comments

Implementing ICH guidelines-compliant validation

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

Analytical methods validation
Procedures and acceptance criteria in calibration limits…

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Added by John Robinson on July 24, 2017 at 6:07am — No Comments

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…

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Added by John Robinson on July 21, 2017 at 5:56am — No Comments

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software

Diligence, complete and proper examination and assessment of the gaps, and correction of the gaps right from the very start of product development are the core characteristics that need to go into implementing risk management of software used in medical devices.

These are the reasons for it:

Lack of proper and complete implementation and gaps in them lead to major drawbacks such as production delays or…

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Added by John Robinson on July 13, 2017 at 6:47am — No Comments

Documenting Software for FDA Submissions

The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:15am — No Comments

Validation the complies with ICH guidelines

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Added by John Robinson on June 5, 2017 at 7:26am — No Comments

Meeting labeling requirements of various drug products

Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and…

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Added by Adam Fleming on May 19, 2017 at 6:17am — No Comments

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

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Added by John Robinson on April 25, 2017 at 6:18am — No Comments

Demonstrating Product Reliability

Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.

The parameters used for quantification of Product Reliability are:

o MTBF or Mean Time Between Failures for products that can be repaired and…

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Added by Adam Fleming on February 13, 2017 at 5:40am — No Comments

Implementing cGMP quality systems and risk management approaches

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…

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Added by Adam Fleming on February 10, 2017 at 6:08am — 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 and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with…

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Added by John Robinson on February 1, 2017 at 4:55am — 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 the global market, and is expected to grow by over 20 percent by 2016.

While many…

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Added by John Robinson on January 23, 2017 at 7:46am — 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 through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…

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

Device Establishment Registration and Listing in line with the FDA’s Proposed Rule

Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.

Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices.…

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Added by Adam Fleming on October 20, 2016 at 5:59am — No Comments

The FDA steps up efforts at bringing about medical device cyber security

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cyber security is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built…

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Added by Adam Fleming on October 12, 2016 at 5:41am — No Comments

The FDA code of federal regulations

FDA Code of Federal Regulations (CFR) is a huge sea of regulations that the FDA has created for regulating all products that come under its purview of regulation. The FDA codes of federal regulations are numbered and cover all products, processes and the activities that go into their creation.

The FDA Code of Federal Regulations is a compendium of codified general and permanent rules the federal…

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Added by Adam Fleming on October 6, 2016 at 5:46am — No Comments

What are the Steps involved to Create a Bullet Proof 510(K)

A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).

A medical device company has to submit a product for PMA when it manufactures or makes changes and…

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Added by Adam Fleming on May 25, 2016 at 6:07am — No Comments

Communilator Will Help Transform Global Medicine

COMMUNILATOR WILL HELP TRANSFORM GLOBAL MEDICINE, DOCTORS WITHOUT BORDERS, INTERNATIONAL COMMERCE, MISSION-WORK AND WAR ZONE COMMUNICATIONS

RantNetwork’s Communilator™ is the most advanced mobile phone language translation application in the world. It is capable of recognizing and translating foreign text, including books, newspapers, and menus in 54 languages and dialects captured with the host’s mobile phone camera delivering translations in over 3,000 language pairs,…

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Added by Kelly Lewis on June 18, 2012 at 4:00pm — No Comments

Misconception – Healthcare Reform Will Impact Medical Science

Many harbor the concept that the recently passed reform legislation – The Patient Access and Affordable Care Act – will mean even greater advances in medical science. This is a misconception.

The reform bill is all about access to care – getting those without insurance to get insurance either through the commercial market place or through Medicaid. This will create at least 31 million more individuals with Medicaid, will keep young adults on their parent’s insurance for a…

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Added by Stephen C Schimpff on March 7, 2012 at 10:30am — No Comments