RAPS Convergence 2024: MedEnvoy Key Takeaways
From September 17th to 19th, 2024, the MedEnvoy team attended RAPS Convergence 2024. This event brought together regulatory affairs…
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EU MDR
EU IVDR
US Agent
General
UK Responsible Person
Egypt Registration Holder
Australian TGA Sponsor
QA Consulting
Swiss Authorized Representative
Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
FDA Human Factor in Medical Device Risk Management
Using any type of product in a manner not intended by its manufacturer has the potential to cause harm, a…
Upcoming Deadline for MDR Conformity Assessment Agreements
As the September 26, 2024, deadline for MDR Conformity Assessment Agreements rapidly approaches, medical device manufacturers are reminded of the…
Predetermined Change Control Plans (PCCP) for Medical Devices
The FDA has recently issued a draft guidance for Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance,…
FDA Guidelines: Medical and In Vitro Diagnostic Device Classification
Classifying your medical device or in vitro diagnostic device (IVD) under the FDA is one of the first steps in…
Australia’s Prescribed List: Reimbursement and Application Tiers
In a previous article (available here), we provided an overview of Australia’s Prescribed List, the medical device reimbursement process…
Personal Protective Equipment (PPE): Regulatory Requirements
Personal protective equipment (PPE) is a daily necessity in many occupations, including healthcare, and it is important to understand their…
Guiding Principles for Medical Devices: AI and Machine Learning
Nearly three years have passed since the US FDA, Health Canada, and UK MHRA jointly identified ten guiding principles in…
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