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 25 years of experience to you in our resources.
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EU MDR Submissions: Post-Market Clinical Follow-Up
What is a post-market clinical follow-up (PMCF)? | 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.
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.
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.
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.
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.
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.
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.