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 the …

EU standard for risk management of medical devices is amended - EN ISO 14971 2019Read More »

As per the earlier notification of health and family welfare medical devices were under voluntary registration scheme. Medical devices has been classified under four categories class A, Class B, Class C, Class D. As per the new notification manufacturers are required to mandatorily register class A and Class B device with CDSCO by September 30, …

manufacturers to speed up Class A and B medical deviceRead More »

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?   Economic operator …

EU MDR Economic OperatorRead More »

There are various function performed by CDSCO under the Drug and cosmetics Act, 1940. It is online process where user can apply ,track, check and Ask queries for NOC, licenses , registration certificates, permission and approvals and download the permission issued by CDSCO.  User have to log in on the portal of CDSCO(www.cdscoonline.gov.in) and fill …

CDSCO Registration FAQs Read More »

Medical devices sector in India will rise exponentially as per the government’s new policy. The current government has some plans or say booster shots for the medical device industry. As per the current policy draft market size of this industry in India is $11bn and its share in global market is around 1.5%. The medical …

Important Medical Device updateRead More »

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 include …

Medical Device Registration in AustraliaRead More »

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 …

QMS perspective for Drug device combinationRead More »

To protect consumers health and for the safety of public life and to avoid serious health hazards FDA recall the medical devices. How do FDA medical devices recalls and why ?It has been seen that the major medical device recall happens with the class 1 category ,as the class 1 category medical devices can create …

How do FDA Medical device recalls?Read More »

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? Operon Strategist is ISO 13485 consultant helps to create the documents for ISO 13485 certification. The medical device manufacturer should …

QMSR(Quality Management System Regulation)Read More »

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 …

FDA Registration FAQsRead More »