MedTech

Quick reference guide - global medical device UDI requirements and timelines

Key steps to help you streamline regulatory process management

Rimsys UDI Overview

A look at the FDA Total Product Life Cycle Advisory Program (TAP)

Are FDA risk classifications and submissions any different for SaMDs? [VIDEO]

An introduction to standards for medtech companies

Why should you invest in your regulatory team? Easy Medical Device podcast interview

Taking SaMDs to market in the US: How is the FDA regulating adaptive machine learning algorithms?

The five guiding principles for machine learning-enabled medical devices using PCCPs

An overview of the Accreditation Scheme for Conformity Assessment (ASCA) Program

Your eSTAR submission questions answered by FDA experts

An overview of the Medical Device Discovery Appraisal Program (MDDAP)

Selecting and working with medtech regulatory approval consultants

Canada medical device regulations

MDR transition example under the extension

Declarations of Conformity

An overview of 21 CFR Part 812

Content of FDA premarket submissions for device software functions

SaaS 101 for medtech regulatory professionals

Global strategy for Unique Device Identifier (UDI) data

Educational resources for medtech regulatory affairs professionals

FDA predicate devices

Medical device audits - preparation and responses

Australian Essential Principles

EU country-specific medical device registration requirements

FDA transition plans for Covid-19-related medical devices

Nonconformance reporting for medical device manufacturers

Regulatory strategy as a competitive advantage

Essential principles

FDA consensus standards

The role of regulatory affairs teams throughout the product lifecycle

IEC 62304: Standard for medical device software

The state of regulatory performance in 2023

6 reasons medtech companies shouldn't delay MDR certification

ISO 10993: Standards for the biologic evaluation of medical devices

STED is dead

An overview of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)

Medical Devices: Comparing standards, regulations, directives, guidance, and laws

Post-market surveillance for medical devices in the European Union

Regulatory should be a revenue function

Ask us Anything ... about China submissions!

FDA databases

IMDRF: International Medical Device Regulatory Forum

Introduction to Notified Bodies

MedWatch: The FDA safety information and adverse event reporting program

An overview of 21 CFR Part 820

What is the FDA eSTAR program?

RAPS wrap-up

FDA Class II medical devices

Brexit overview for medical device manufacturers

The RegUP rundown

IVDR: In Vitro Diagnostic Regulation within the European Union

Ask us Anything ... about UDI!

CE marking guide for medical devices in the European Union

Oh No! How to recover lost medical device certificates

Rimsys POV: new EUDAMED timeline

Class III medical devices in the United States

BUDI-DI - Basic UDI explained

ISO 14971: risk management for medical device manufacturers

FDA PMA submission process: a beginner's guide

FDA medical device registration process - getting new products to market in the U.S.

EU MDR overview - a major update to European medical device regulations

ISO 13485 overview - quality management requirements for medical device companies

FDA listed, cleared, approved, granted - what IS the difference?

21 CFR Part 11 for regulatory affairs teams

Software as a medical device (SAMD) - classification overview

PSUR: Periodic safety update reports for medical device and in vitro diagnostic products

De Novo classification process: a beginner's guide

GUDID: An overview of the FDA's Global Unique Device Identification Database

MDSAP - the ultimate guide to the medical device single audit program

The ultimate guide to the China NMPA UDI system and database

FDA 510(k) - a beginner's guide

A primer on medical device classification

EUDAMED and UDI in Europe: an overview

The ultimate guide to the EU MDR/IVDR UDI

The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR)

Competent Authority, Notified Body, Authorized Representative – who’s who and what do they do?

The 510(k) application: if content is king, then communication is queen

Is a medical device accessory a medical device?

Podcast – Streamlining the MDSAP device marketing authorization and facility registration process

MDSAP device marketing authorization and facility registration