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MedWatch: The FDA safety information and adverse event

WEBIn 1993 the FDA introduced the MedWatch program designed to collect voluntary reports of adverse reactions and quality problems of drugs and medical devices, along with all …

Actived: 8 days ago

URL: https://www.rimsys.io/blog/medwatch-the-fda-safety-information-and-adverse-event-reporting-program

Rimsys Platform Medical Device Regulatory Information Software

WEBA single, cloud platform for end-to-end regulatory process digitization and automation—designed by and for regulatory affairs professionals. Request a demo. …

Category: Health Go Health

FDA medical device registration process

WEBAny organization involved in the production or distribution of a medical device intended for use in the United States is required to register annually with the FDA. Establishment …

Category: Medical Go Health

RIM 101: what is regulatory information management

WEBRegulatory Information Management (RIM) refers to a category of software solutions that are designed to support and streamline the activities of regulatory affairs (RA) teams. …

Category: Health Go Health

IMDRF: International Medical Device Regulatory Forum

WEBThe International Medical Device Regulatory Forum (IMDRF) is a body of medical device regulatory specialists from around the world working together to standardize regulations …

Category: Medical Go Health

The Only Holistic RIM Software for Medtech Rimsys Regulatory

WEBThe Rimsys Platform. The Rimsys Regulatory Information Management Platform digitizes and automates regulatory activities in a single cloud-based platform, helping regulatory …

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ISO 14971: risk management for medical device manufacturers

WEBUnder ISO 14971:2019 a manufacturer is required to document risk analysis activities and the results of those activities in a risk management file. These should …

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The ultimate guide to the EU MDR and IVDR general safety and

WEBAnnex I of the EU MDR and IVDR details the specific requirements of the General Safety and Performance Requirements (GSPRs). The GSPRs are broken down into three (3) …

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An overview of the UK Medicines and Healthcare Products

WEBThe Medicines and Healthcare products Regulatory Agency (MHRA) is the gatekeeper of that market and one of the world’s most influential regulatory bodies. …

Category: Medicine Go Health

The ultimate guide to the EU MDR/IVDR UDI

WEBThe EU Medical Device Regulation (“MDR”) and EU In Vitro Diagnosis Regulation (“IVDR”) introduce two new systems for information exchange: UDI (Unique Device Identifier) for …

Category: Medical Go Health

Software as a medical device (SAMD)

WEBMedical Device Software is classified by the European Commission’s Medical Device Coordination Group (MDCG) into Class I, II, or III. For devices falling under the IVDR, …

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The role of regulatory affairs teams throughout the product

WEBRegulatory affairs (RA) professionals have responsibilities at each stage of the product lifecycle and will collaborate with most sections of the business on one or …

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CE marking guide for medical devices in the European Union

WEBCE marking is a symbol that consists of “CE, “ which is the abbreviation of the French phrase "Conformité Européene" meaning "European Conformity".The term initially used …

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Canada medical device regulations

WEBThe regulation of medicaldevices in Canada is driven by The Food and Drugs Act (R.S.C., 1985, c. F-27). This act includes food, drugs, cosmetics, and devices. The regulation …

Category: Food, Medical Go Health

Competent Authority, Notified Body, Authorized Representative

WEBCE mark example Authorized Representatives. According to EU directive 2017/745 and 2017/746, it is a legal requirement to appoint a European Authorized Representative …

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Quick reference guide

WEBKeeping track of country-specific UDI requirements and timelines is a big challenge for RA teams. This guide consolidates timeline information and device class requirements …

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EU country-specific medical device registration requirements

WEBThere are 27 member states that belong to the European Union (EU), along with additional countries that participate in the European Economic Area (EEA) and the EU’s single …

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