17 Sep Date September 17, 2024 Author admin Here are some of the common mistakes that can occur during the submission of a medical device manufacturing license application in India Incomplete or Inaccurate Information: Missing Documents: Not including all the required documents as per the CDSCO guidelines...
17 Sep Date September 17, 2024 Author admin What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017/745) and the In Vi...
17 Sep Date September 17, 2024 Author admin Case Study 1: U.S. Endotracheal Tube Manufacturer – Achieving 21 CFR 820 Compliance & 510(k) Submission with Medfins International. Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...
17 Sep Date September 17, 2024 Author admin What is a Free Sale Certificate (FSC)? An official document issued by the Central Licensing Authorities or State Licensing Authorities that certifies a medical device is...
10 Sep Date September 10, 2024 Author admin The EU In Vitro Diagnostic Regulation Introduction The EU In Vitro Diagnostic Regulation (IVDR 2017/746) significantly overhauled the regulatory landscape for in vit...
10 Sep Date September 10, 2024 Author admin Class C and D medical device import registration Government Authority (CDSCO) The Indian Medical Device Regulation, established by the CDSCO, must be followed by all medical de...
10 Sep Date September 10, 2024 Author admin Medical Device Regulation in India By 2025, the rapidly expanding Indian healthcare sector will generate $280 billion in revenue. One of the top 20 medical device ma...
09 Sep Date September 9, 2024 Author admin What is UDI in the EU Context? Definition : The UDI is a series of numeric or alphanumeric characters that provides a globally unique identifier for medical dev...
09 Sep Date September 9, 2024 Author admin Introduction to Technical Documentation under EU MDR 2017/745 Technical Documentation under the EU Medical Device Regulation is a thorough collection of documents proving a medical device's co...
09 Sep Date September 9, 2024 Author admin EUDAMED : European Database on Medical Devices What is EUDAMED It's a European Data bank on Medical Devices, is a key element under the EU Medical Device Regulation (MDR 2017...