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FDA PMA submission process: a beginner's guide

WEBThe difference in complexity between a PMA and 510(k) also affects the time needed to process the submissions. The FDA typically accepts or rejects a 510(k) …

Actived: 5 days ago

URL: https://www.rimsys.io/blog/pma-submission-process-beginners-guide

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 …

Category: Medical Go Health

Class III medical devices in the United States

WEBSoftware defined as a medical device (Software as a Medical Device or SaMD), which meets the risk profile of a Class III device. This may include diagnostic software that is …

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

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, …

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 …

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

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

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

Rimsys UDI Medical Device Regulatory Information Management …

WEBCentralized management with country-compliant record generation. Manage top-level “Universal” UDI information and auto-generate country-compliant formats for the U.S., …

Category: Health 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 …

Category: Health Go Health

De Novo classification process: a beginner's guide

WEB1997. Congress enacted a De Novo classification process to help limit the unnecessary use of FDA and industry resources on devices for which general controls (or general and …

Category: Health Go Health

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 …

Category: Health Go Health

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) …

Category: Health Go Health

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

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

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 …

Category: Health Go Health