MedTech Regulatory Insights Feb 2025
The FDA has released a draft of new recommendations aimed at improving the performance accuracy of pulse oximeters, particularly across […]
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MedTech Regulatory Insights January 2025
On 16 October 2024, the Medical Device Coordination Group (MDCG) published the revised guidance titled “Application of MDR Requirements to
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UncategorizedSTATISTICS 101: TYPES OF DATA
An understanding of statistics is useful whenever you are anaylsing any data and want to take actions based on that.
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UncategorizedSTATISTICS 101: TYPES OF DISTRIBUTIONS
In the last blog, we talked about different types of data. Data, as we know, can be discrete or continuous.
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UncategorizedWHO Prequalification of In-Vitro diagnostics
WHO PQ – What, How and WHY ? World Health Organisation Prequalification (WHO PQ) programme helps countries having low and
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UncategorizedUncovering the Impact of Endocrine Disrupting Substances in Biological Evaluation of Medical Devices
In recent years, there has been growing concern about the presence of endocrine-disrupting substances (EDS) in various products, including medical
REPROCESSING OF REUSABLE MEDICAL DEVICES: INTRODUCTION
Hello readers! We are launching another blog series on reprocessing of reusable medical devices. The idea is to serve you
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UncategorizedBlog on Biomaterials
Thanks to their adaptability, resilience, and cost-effectiveness, biomaterials have long been a mainstay in medical device manufacturing. However, the environmental
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UncategorizedARE YOU READY TO MOVE TO ELECTRONIC IFUs?
Are you one of those who thinks uploading instructions for use (IFU) on the website is enough to meet the
ARE YOU READY TO MOVE TO ELECTRONIC IFUs? Read More »
UncategorizedGOOD DOCUMENTATION PRACTICES
Good Documentation Practices (GDP) serve as the foundational elements of a robust Quality Management System. Mandated by numerous regulatory bodies,
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UncategorizedAN INTRODUCTION TO MEASUREMENT SYSTEM ANALYSIS
Measuring instruments and measurement systems are at the core of any manufacturing industry. The goal of every organization that strives
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UncategorizedREPROCESSING OF REUSABLE MEDICAL DEVICES: WORST-CASE SELECTION
All right, we’re back with more content on reprocessing of reusable medical devices. We introduced this topic in our last
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UncategorizedUnderstanding the ISO 80369 Standards for Medical Connectors
Small-bore connectors, which have an opening size of less than 8.5 mm, are essential components in various medical devices used
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UncategorizedClinical-evaluation-of-medical-devices-III
Hello and welcome to another brainstorming blog to discuss the clinical evaluation of medical devices! In our previous blog post,
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UncategorizedUsability-Evaluation-of-Aseptic-Presentation
Aseptic presentation plays a crucial role in ensuring patient safety and preventing infections in healthcare settings. Proper packaging and presentation
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UncategorizedAn introduction to the IEC 60601 standard.
Medical devices powered by electricity offer life-saving capabilities, yet they also present risks, especially when invasive procedures bypass the body’s
An introduction to the IEC 60601 standard. Read More »
UncategorizedHOW TO PERFORM USER RESEARCH?
Hello readers! We’re back (after quite some time, yeah!) with a long-due update on methods of user research. This is
HOW TO PERFORM USER RESEARCH? Read More »
UncategorizedCOMPLIANCE WITH ELECTRONIC IFUs
– PRACTICAL GUIDE Well, in our previous blog on electronic-IFUs, we discussed that e-IFU requirements are not mandatory to comply
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UncategorizedNational Policy in R&D and Innovation
India takes pride for being known as ‘Pharmacy of the world’. The country has made it possible by becoming one
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UncategorizedHOW TO CREATE A DESIGN HISTORY FILE FROM SCRATCH!
What is a Design History File (DHF)? The design history file is a compilation of records that describes the design
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UncategorizedHow to write an intended use for a medical device?
Hello readers, we’re back with another topic in the series of Usability Engineering for Medical Device. The last blog described
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UncategorizedeSTAR Program: Revolutionizing FDA Regulatory Process
In the ever-changing landscape of medical device regulation, technology plays a vital role in improving efficiency and ensuring robust processes.
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UncategorizedAsean mdd
The Association of South East Asian Nations (ASEAN) is a regional bloc composed of ten countries: Brunei Darussalam, Burma, Cambodia,
ISO 10993ISOISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Test for irritationISO 10993ISO
The safety of biological evaluation is one important piece of the puzzle to demonstrate the safety of a medical device.
Medical Device Usability Engineering: Using Specifications
Our last blog in the series of Usability Engineering for Medical Device highlighted mandatory steps of the usability process. It
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UncategorizedHISTORY OF MEDICAL DEVICES REGULATION IN THE USA
In the first part of this series on medical device regulation in the USA, we are discussing the chronology of
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UncategorizedBest Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
USFDA (United States Food and Drug Administration) regulates medical devices in the USA. According to USFDA, medical devices are classified
Sterilization of Medical Devices
Medical device sterilization is essential to maintain the safety of patients and healthcare professionals. Improperly sterilized medical devices can produce
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UncategorizedApplying Usability Engineering to Medical Devices
Usability engineering for medical devices, or human factors engineering, is a concept of understanding interactions between the user and the
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UncategorizedDo we need PMCF every time for every device?
Cath Solutions Inc. recently got a CE mark and is keen to start selling. While trying to register with the
Do we need PMCF every time for every device? Read More »
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