operon strategist

European standard for risk management of medical devices is amended - EN ISO 14971 2019

EN ISO 14971 2019 Two years’ back EN ISO 14971 2019 Medical Devices – Application of Risk Management to medical devices was published. Harmonized Standard EN ISO 14971 2019 has already replaced the previous standard EN ISO 14971:2012 which was only harmonized for three directives MDD, AIMDD and IVDD. There were content deviations in theContinue reading “European standard for risk management of medical devices is amended - EN ISO 14971 2019”

CDSCO Registration FAQs 

CDSCO Registration FAQs Who can register for CDSCO online portal?  Corporate, Indian Agent, Importer, Foreign Enterprise holding Indian Subsidiary, Cosmetics, Ethics Committee, Formulation R&D Organization, BA/BE Approved Sites, Sponsors(BA/BE & CT)  How will I login to CDSCO online portal ? Frist go to homepage and check on ‘sign in’ under with you will get aContinue reading “CDSCO Registration FAQs ”

EU MDR Economic Operator For the medical device manufacturer it is important to understand the role of EU MDR economic operator .These operators are also referred with the acronym MAID. The role of economic operator is tied to legal liability so one should understand how they fit in economic operator framework. Who are EU MDR economic operators?   Continue reading

QMS perspective for Drug device combination

To begin with, we will first understand QMS. Quality Management system is a structured process and procedure which covers all aspects of designing, manufacturing, structuring, risk management, product labeling, clinical data, storage and more. This Article explains QMS perspective for drug device combination for a manufacturing company. Combination product regulated by FDA Guidance. Combination product means productsContinue reading “QMS perspective for Drug device combination”

Medical Device Registration in Australia

Medical Device Registration in Australia Process: Therapeutic Goods Administration (TGA) oversees regulation of medical devices in Australia through Australian Regulatory Guidelines for Medical Devices (ARGMD) and these guidelines closely resemble with the regulations put into place by the European Union. To gain access to the Australian market, medical device and IVD manufacturers need to includeContinue reading “Medical Device Registration in Australia”

How do FDA Medical device recalls?

What is the process of Medical device recalls? If the manufacturer or importer fails to recall their product FDA may issue recall order under 21CFR 810. Medical devices recall usually conducted voluntarily. Recall means removing or correcting the product. According to the definition of FDA, Recall means a firm’s removal or correction of a marketed product that theContinue reading “How do FDA Medical device recalls?”

QMSR- Quality Management System Regulation

This Blog speaks about harmonization of FDA QSR and ISO 13485. Those who are new to the industry probably have so many questions like How do we start? Which Regulations need to follow? what is QSMR? To begin with, we will first understand QMS. Quality Management system covers designing, manufacturing, structuring, risk management, product labeling, clinicalContinue reading “QMSR- Quality Management System Regulation”

FDA Registration FAQ’s

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 FAQs What is FDA and FDA Registration? FDA is Food and Drug Administration Agency formed for consumer’s safety and security. Any medical device manufacturer who wish to sellContinue reading “FDA Registration FAQ’s”

Roles of PRRC (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 regulatory compliance. PRRC’s plays vital roles and responsibilities in setting up the plants forContinue reading “Roles of PRRC (Person Responsible for Regulatory Compliance)”

IMPLICATIONS FOR DRUG-DEVICE COMBINATION PRODUCTS

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, neurological,Continue reading “IMPLICATIONS FOR DRUG-DEVICE COMBINATION PRODUCTS”