The Design History File (DHF) is a structured document that captures the entire design and development journey of a medical device. It serves as a formal record, ensuring all the necessary design and development processes are documented in an organized manner What Are the FDA Guidelines For DHF? The design history file requirements are given […]
Is DHF (Design History File) Required for Class I Devices? Read More »
An Overview: The CE mark signifies that the product you are holding has been tested and certified to meet European Economic Area safety, health, and environmental requirements. The European Economic Area (EEA) is made up of the European Union’s (EU) member countries as well as a few other European countries that are not nominal EU
3 Key Questions on CE Marking and QMS Compliance Read More »
Navigate Complex Drug-Device Regulations with Expert Support Bringing a co-packaged combination product to market requires precise regulatory classification, documentation alignment, and compliance with both drug and device regulations. At Operon Strategist, we help manufacturers like you simplify this complex process and ensure your product meets all regulatory requirements in the USA (FDA), India (CDSCO), and
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Understanding ISO 13485 Certification and Its Role in Medical Device Registration ISO 13485 is a critical standard implemented by organizations involved in designing, producing, installing, and servicing medical devices. It plays a crucial role in auditing processes for manufacturers, but there is often confusion among industry stakeholders about who can certify ISO 13485, which is
Choosing The Right Agency For ISO 13485 Read More »
ISO Standards for Medical Device Manufacturers – Ensure Compliance & Quality The International Organization for Standardization (ISO) plays a vital role in shaping global medical device standards. These standards ensure safety, performance, and regulatory compliance—helping manufacturers build high-quality devices that meet FDA, EU, and other global requirements. While ISO standards are not always mandatory, they
Most Important ISO Standards For Medical Devices Read More »
The TGA accepted MMDR recommendation 21 to set timeframes that reflect worldwide benchmarks and the standard lifecycle of a medical device for evaluation and inclusion in the Australian Register of Therapeutic Goods (ARTG).Australia’s regulatory framework for therapeutic goods is undergoing a number changes in response to the MMDR. In 2019, an independent reviewer compared the
TGA publishes latest medical device application processing times Read More »
India is heavily dependent on foreign countries for high end medical devices .To reduce this dependency and make India self -reliant government working on various schemes. Government of India encouraging and supporting Entrepreneurs and medical device manufacturer with schemes like PLI i.e Production Linked Incentives and Medical device parks . These initiatives will play crucial
High Time for Nation to Produce Indigenous Medical Equipment Read More »
What is EU Authorized Representative? EU Authorized Representative means any natural or legal person established within the Union who has obtained and accepted a written mandate from a manufacturer, located outside the European Union, to act on the manufacturer’s behalf concerning specified tasks given in MDR 2017/745. If the manufacturer is located outside the European
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What is PSUR?Periodic Safety Update Report (PSUR) is document encompassing a summary of data procured from post market surveillance. In accordance article 86 of EU MDR/745, manufacturers of devices falling under moderate and high-risk classes, are obliged to prepare Periodic Safety Update Report. Operon strategist is a Turnkey project consultant ,we help our clients to
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Does your organization have items that were allowed in emergency use of authorization, use approval to get to showcase? If you need to keep those items available post-EUA, do you have any plan what you want to do now to get prepared? This article will spread some light on above cited questions and will brief
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