Resources Hub
Welcome to the Asphalion Resources Repository
Asphalion
MedTech Blog
A compilation of insightful articles on MedTech Regulatory Affairs.
Asphanet Pharmacovigilance Interactive Map
Click on the countries to learn about the local safety requirements.
Glossary of Pharmaceutical
Regulatory Acronyms
Comprehensive glossary that provides clear definitions of pharmaceutical achronims.
Global Pharmaceutical
Regulatory Agencies Directory
Interactive directory of the main pharmaceutical regulatory agencies around the world.
Regulatory
Resources Library
Find here a collection of resources that can be useful in your day-to-day: Flyers, infographics, videos, webinars, whitepapers, etc.
We put at your disposal these useful and handy tools:
FLYER | FDA Consultation Procedures
Navigate FDA Requirements with Confidence
FLYER | Design and Development for Medical Devices: Navigating ISO 13485
Design and Development (D&D) for Medical Devices
FLYER | FDA De Novo Authorization procedure
Overview ofthe De Novo Pathway
FLYER | Medical Device Software Standard IEC 62304:2006
Medical Device Software Standard IEC 62304:2006 /Amd 1:2015
LCM- Week | Electronic Application Form (eAF)
The Electronic Application Form (eAF) is a unified EU form used for human and veterinary MAAs, variations, and renewals. It combines PDF for input and XML for data transfer, enabling data import/export, auto-copy, self-validation, and access to standardized term catalogues (EUTCT)—streamlining regulatory submissions and reducing manual input.
VIDEO | First quarter 2025 highlights
We have compiled our quarterly highlights in a video for you to have an easy-to-scan summary of our newest insights
FLYER | Regulation (EU) 2017/745: Understanding its impact on Drug-Device Combinations in Directive 2001/83/EC
Drug–device combination products (DDCs) and how are they classified in Europe
WEBINAR | Mastering the Safety Management Plan in Clinical Trials: Key points
Webinar recording
PV-month | The Importance of SAE Management in Clinical Trials
PV-month | Digital Solutions for Local Activities
A Cost-Effective Solution for Literature Searches
Have a look at this infographic about a centralized and cost-effective solution for literature searches thanks to AsphaSearch
FLYER | EU Authorized Representative, UK Responsible Person and US Agent
When manufacturers of medical devices operate outside certain regulatory regions, they must appoint an official representative to ensure compliance with local laws and regulations.
PV-month | The Evolution of Veterinary Pharmacovigilance in Recent Years
FLYER | Understanding Usability: Definition and principles
By prioritizing usability, devices achieve their intended purpose while protecting patients and users.
FLYER | Risk Management ISO 14971
Risk Management for Medical Devices: Navigating ISO 14971:2019
FLYER | EU Authorized Representative, UK Responsible Person, US Agent
The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer, and provide a copy of the mandate to the competent authority, upon request.
