This blog discusses the harmonization of FDA QSR with ISO 13485. Those new to the industry are likely to have a lot of questions, such as, “How do we get started?” Which regulations should be followed? What is QSMR? ISO13485 is an international quality management system regulation, although the United States has its own set […]
Introduction of QMSR (Quality Management System Regulation) Read More »
FDA registration FAQs : Operon Strategist cleares all doubts related food facility registration and other submissions FDA is an agency within the US health and welfare department, a regulatory body which provides some guideline for setting up the plants of medical devices. FDA registration is depend on the class of the device. Certain class of
FDA Registration FAQs Read More »
What is PRRC? PRRC is acronym of “Person Responsible for Regulatory Compliance”. EUMDR introduces new requirements for the medical devices manufacturers, which explains the roles of PRRC. according to the new regulation of EUMDR, which came into force on 26 May 2021 the medical device manufacturer should have a PRRC to keep an eye on
Roles of PRRC (Person Responsible for Regulatory Compliance) Read More »
IVDR Verification of class D IVDs This content has guidance for establishing the activities of Notified Bodies for the verification process of class D IVD devices. According to the law on in vitro diagnostic Medical Devices (IVDR), Regulation (European) 2017/746, class D devices need to demonstrate their conformity assessment via the involvement of a notified body.
IVDR Verification of class D IVDs by notified bodies Read More »
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices for with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical
Classification of General Hospital-Orthopaedic Medical Devices Read More »
Welcome to our comprehensive guide on the intricate world of In Vitro Diagnostic (IVD) medical devices regulations. In this guide, Operon Strategists shed light into the core principles, pre-market and post-market considerations, quality management, and the global market landscape for IVDs. Let’s embark on this journey to help you navigate the regulatory waters successfully. What is IVD’s:
A Guide to In Vitro Diagnostic Medical Devices Regulations Read More »
The drug -device combination (DDC) products are the therapeutic or diagnostic products that combine drugs, devices or biological products which leads to safe and effective treatments. It helps in targeted drug delivery, localized drug administration and individualized medicine therapy. With the advancement in technology drug-device combination products have developed a unique form of medicinal products that has cardiovascular,
IMPLICATIONS FOR DRUG-DEVICE COMBINATION PRODUCTS: MDR ARTICLE 117 Read More »
Importance of Medical Device Risk Management Risk management plays a crucial role in the lifecycle of medical device product development. It serves as a vital tool for manufacturers in ensuring the reliability and safety of the final product, minimizing the likelihood of malfunctions or harm. The primary objective of the risk management process is to
Medical Device Risk Management As Non-Negotiables for Managing Business Risk Read More »
EU MDR compliance for Legacy Devices: An Overview Legacy devices encompass a range of medical products including medical devices, active implantable medical devices, and in vitro diagnostic devices. These devices have been granted valid certificates under the Medical Devices Directive (MDD) or Active Implantable Medical Device Directive (AIMDD), with CE marking certificates issued according to
EU MDR Compliance for Legacy Devices Read More »
Saudi Arabia SFDA Guidance on UDI A wide range of medical devices are available in the market. The rising concerns related to medical devices like patients’ safety and supply chain management has forced the introduction of a single, unique, globally harmonized identification system for every device. UNIQUE IDENTIFICATION IDENTIFIER The US FDA has established the
Extends Deadlines for Saudi Arabia SFDA Guidance on UDI Read More »
