Thera Resources

Thera Resources

Thera Resources provides expertly advised resources for you to use towards improving your literature reviews and evidence based-reports. We are experts in the development of well-written regulatory documents, and bring over 20 years of experience to you in our resources.

DRUGDOCS®

DRUGDOCS® provides health professionals with current, evidence-based information on the drugs they prescribe. Provided by Thera-Business and collected using an independent, comprehensive and non-biased literature search strategy.

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Quick Guide to an EU MDR State of the Art Review

SOTA Literature Review

Quick Guide to an EU MDR State of the Art Review | Download

Five Key Steps for your Literature Review

Five Key Steps for your Literature Review

Develop your Literature Review in 5 Key Steps | Download

EU MDR Compliance

EU MDR 2021 Deadline Leaflet

EU MDR 2021 Deadline is Quickly Approaching. Are You Ready? | Download

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Download our publication now!

Submitting the form below will allow you to access our guide. By providing us with your contact details, you are agreeing to the possibility of us getting in touch with you (one time only) with related information.

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Download our publication now!

Submitting the form below will allow you to access our guide. By providing us with your contact details, you are agreeing to the possibility of us getting in touch with you (one time only) with related information.


Other Resources

We are driven by the knowledge that our work is important and makes a difference to patient care. That’s why we’re passionate about actively providing you with the most reliable, and informative resources available today.

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Key Resources

CADTH

CADTH is an independent, not-for-profit organization responsible for providing health care decision-makers with objective evidence to help make informed decisions about the optimal use of health technologies.

NIHR - National Institute for Health Research

The NIHR Journals Library website provides access to information about research funded by the National Institute for Health Research (NIHR).

ECRI

ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific.

PubMed

PubMed® comprises more than 30 million citations for biomedical literature from MEDLINE, life science journals, and online books.

Cochrane Library

The Cochrane Library (ISSN 1465-1858) is a collection of databases that contain different types of high-quality, independent evidence to inform healthcare decision-making.

CRD Database

The Database of Abstracts of Reviews of Effects (DARE) and the NHS Economic Evaluation Database (NHS EED) provide access to quality assessed systematic reviews, Cochrane systematic reviews and protocols, and economic evaluations of health and social care interventions.

AHRQ

The Agency for Healthcare Research and Quality (AHRQ) is the lead Federal agency charged with improving the safety and quality of America’s health care system.

NICE - The National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care.

IC/ES

ICES is a not-for-profit research institute encompassing a community of research, data and clinical experts, and a secure and accessible array of Ontario's health-related data.


EU MDR

Home Page

The EU has a competitive and innovative medical devices sector, characterised by the active roll of small and medium-sized enterprises.

Complete Regulation ((EU) 2017/745)

This regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.

In-Vitro Diagnostics Regulation ((EU) 2017/746)

This regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in-vitro diagnostic medical devices for human use and accessories for such devices in the Union.


FDA - Medical Devices

Home Page

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. The FDA explains many aspects of medical device laws, regulations, guidances, and policies, encompassing the entire product life cycle.

Overview of Device Regulation

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.


FDA - Pharma

Development and Approval of Drugs

CDER does not test drugs, although the Center’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.

Drug Approval Process PDF

FDA’s New Drug Application (NDA) Review.

The Drug Review Process

Stages of drug development and review, from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.


Health Canada

Home Page

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Guidance Document

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations.

Quality Systems (ISO 13485)

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement.

Medical Device Application Forms

A list of medical device application forms.

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