MedTech I.Q.

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All Blog Posts (1,319)

Brexit: May to meet UK financial services chiefs

The Prime Minister is set to meet with business leaders from the UK’s financial services industry as the government attempts to secure a Brexit deal that will include the sector.

Theresa May will talk with Barclays’ chief Jes Staley and Goldman Sachs International boss Richard Gnodde among others on Thursday.

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Added by Compliance4all on January 11, 2018 at 4:46am — No Comments

Digital Marketing for Pharmaceutical companies offers tremendous opportunities

There is enormous potential for digital marketing for pharmaceutical companies. Proper exploitation of the social media can take pharmaceutical companies to their market in a more pinpointed and accurate manner than traditional marketing.

Gone are the initial days of reluctance on the part of pharmaceutical companies to…

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Added by John Robinson on January 11, 2018 at 4:33am — No Comments

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU's regulatory body, the MDD.

The Design History…

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Added by John Robinson on January 10, 2018 at 4:53am — No Comments

An understanding of Pharmaceutical Regulatory Affairs

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

pharmaceuticalRegulatoryAffairs The primary aim of Pharmaceutical Regulatory Affairs is to ensure compliance with regulations that apply to every stage and process…

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Added by Compliance4all on January 10, 2018 at 4:50am — No Comments

IBM marks more than 100,000 patents in 25 years with AI, cyber security enhancements

The inventors who serve as the backbone of International Business Machines Corp. passed a significant milestone this year, and a diverse array of fields including artificial intelligence (AI), the cloud, and cyber security are all the richer for it.

The Armonk, N.Y.-based tech giant used this year’s Consumer Electronics Show…

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Added by Compliance4all on January 9, 2018 at 5:06am — No Comments

Design Control for Medical Devices



Design Control for Medical Devices 3 https://globalcompliancepaneltraining.files.wordpress.com/2018/01/design-control-for-medical-devices-3.jpg?w=650&h=650 650w,…

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Added by John Robinson on January 9, 2018 at 4:56am — No Comments

Aspects of Regulatory History in the US

The beginnings of all that the USFDA regulates can be traced right to the early decades of the founding of the nation. In a sense, the FDA, even if came to be called by that formal name much later; embodies the discipline and value set that the new created nation sought to represent. Regulation of all aspects of American life was deeply ingrained…

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Added by John Robinson on January 8, 2018 at 5:22am — No Comments

Army Chief stresses on indigenous defence technology

Asserting that there is huge requirement to modernise the armed forces, Army Chief General Bipin Rawat on Monday called for self-reliance in terms of defence equipment manufacturing. Speaking at the Army Technology Seminar in Delhi, General Rawat said: ” the time has come to ensure that we fight the next war with homemade solutions.”
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Added by Compliance4all on January 8, 2018 at 5:03am — No Comments

Good Documentation Practice Guideline is simple: just write

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.

Good Documentation…

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Added by John Robinson on January 5, 2018 at 5:06am — No Comments

What is risk-based monitoring?

Sponsors of clinical studies adapt many methods that are aimed at reducing the complexity of clinical trials. They also look for methods by which they can increase the efficacy of the results, while keeping the costs low. Risk-based monitoring is one of these methods.

How is risk-based monitoring understood?One can understand risk-based monitoring in several ways. This varied understanding is because there is no one definition or…

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Added by John Robinson on January 4, 2018 at 5:04am — No Comments

FDA Warning Letters – an understanding

As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority.

The FDA issues a Warning Letter to a company when it determines, following…

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Added by John Robinson on January 3, 2018 at 4:50am — No Comments

Tougher FDA import rules are aimed at putting strict controls on imports

Tougher FDA import rules are aimed at putting strict controls on imports 3 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/tougher-fda-import-rules-are-aimed-at-putting-strict-controls-on-imports-3.jpg?w=1400 1400w,…

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Added by John Robinson on December 14, 2017 at 4:30am — No Comments

Best Practices in Vendor Risk and Compliance Management



Best Practices in Vendor Risk and Compliance Management.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/best-practices-in-vendor-risk-and-compliance-management.jpg?w=838 838w,…

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Added by John Robinson on December 13, 2017 at 4:45am — No Comments

FDA Requirements for ensuring Premarketing Clinical Trial Safety



FDA Requirements for ensuring Premarketing Clinical Trial Safety 2 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/fda-requirements-for-ensuring-premarketing-clinical-trial-safety-2.jpeg?w=844&h=562 844w,…

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Added by John Robinson on December 12, 2017 at 5:08am — No Comments

The FDA's requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products…

The FDA's requirements for non-IND Foreign Clinical Studies 2

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Added by John Robinson on December 11, 2017 at 5:41am — No Comments

The Investigational New Drug Applications mechanism in the USA



The Investigational New Drug Applications mechanism in the USA.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-investigational-new-drug-applications-mechanism-in-the-usa.jpg?w=866&h=650 866w,…

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Added by John Robinson on December 8, 2017 at 5:40am — No Comments

The increasing role of the social media in healthcare



 

The increasing role of the social media in healthcare 6 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-increasing-role-of-the-social-media-in-healthcare-6.jpg?w=862&h=574 862w,…

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Added by John Robinson on December 7, 2017 at 6:45am — No Comments

Technical Writing for the Pharma, Device and Biotech Industries



Technical Writing for the Pharma, Device and Biotech Industries 3 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/technical-writing-for-the-pharma-device-and-biotech-industries-3.jpg?w=690&h=660 690w,…

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Added by John Robinson on December 6, 2017 at 5:53am — No Comments

Quality Risk Management in the FDA-Regulated Industry



Quality Risk Management in the FDA-Regulated Industry.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/quality-risk-management-in-the-fda-regulated-industry.jpg?w=874&h=490 874w,…

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Added by John Robinson on December 5, 2017 at 6:08am — No Comments

Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an…

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Added by John Robinson on December 4, 2017 at 4:50am — No Comments

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