How To Easily Get MDSAP Certification? A Step-by-step Guide
Medical device single audit program (MDSAP) aims to accelerate international medical device regulatory harmonization. This streamlined, efficient, and effective regulatory model promotes worldwide alignment of international regulatory requirements. MDSAP helps medical...
Medical Device Single Audit Program: MDSAP Consultation Service
Medical device single audit program (MDSAP) is a global initiative designed to streamline the regulatory compliance process in participating countries. US, Canada, Brazil, Japan, and Australia are MDSAP members and participating countries of the program. We at...
Global Regulations for Custom-Made Medical Devices
Custom-made medical devices have a crucial role in modern healthcare system. Owing to their unique nature, custom-made medical device manufacturers may face several regulatory challenges. This guide will help you navigate the top global regulations for...
12 Tips for Preparing Medical Device Technical File
A medical device technical file is a structured dossier that contains all essential documentation required for demonstrating regulatory compliance. Additionally, it is used to demonstrate the medical device’s safety, performance, and quality to regulatory authorities....