Supplier Qualification Process in Medical Device Manufacturing
A Medical Device is as good as its parts, this eventually makes supplier qualification process extremely important in Medical Device Design & Development. FDA 21 CFR 820.50 and ISO 13485:2016 Section 7.4 highlights major requirements for purchasing...
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Medical Device CAPA Process : Importance, benefits and implementation
A Medical Device Contract Manufacturing Organization is never at rest. With diversity of projects from different segments of Medical Device Industry, the possibilities of errors, risks, and upgrades are infinite. Every new project comes with its challenges...
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Medical Device Labeling: Importance, Do’s & Don’ts
A simple purchase decision for a regular use commodity is often influenced by the information printed on the product label. A Medical Device or Product is a high-risk commodity. For such products or devices labeling & packaging plays a crucial role in the...
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USA Health Panel has made anxiety level checks mandatory for US Population! Johari’s Possible Solution…
With a significant rise in anxiety levels in the US population, United Nations Human Health & Service department-led Health panel has come up with an initiative to make mental health & anxiety checks mandatory for all adults up to 65 years of age. An...
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Is Post Market Design Enhancement a roadblock for your Medical Device Market Sustainability?
Medical Device Development is a highly regulated task involving different talents including Engineering, Manufacturing, Designing, Regulatory& Quality, Sales & Marketing. Medical Device Contract Manufacturing unit needs the joint efforts of all these...
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Pain Relief by Electrotherapy: A brief history & Useful Indications
Discovery of Electrotherapy was a serendipity. You don't believe it? We'll tell you how! A student at the University of Halle in Germany discovered that electricity caused an improvement in paralysis. Electricity improved heart rate, sleep, and induced...
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Understanding Bill of Materials (BOM) for Medical Devices: A Comprehensive Guide
What is BOM (Bill of Material)? A comprehensive list comprising prices involved in the development of a medical device is referred to as the Bill of Material (BOM). This may include Raw Materials, Assemblies, Sub-Assemblies, Work Force, Machinery, and...
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How to Bridge the Gap between Market Research and Medical Device Development Team?
Medical Device Development is a highly regulated task involving multiple stages and different talents. The marketers in the MedTech firms are the first ones to interact with a new product idea. From day one when the discussion around a project begins to...
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How Vibroacoustic Therapy Works for Insomnia & Anxiety?
Here we are, with another interesting device for insomnia! Do you also have the best sleep in a moving vehicle? If yes, have you ever tried finding out why? It’s because vibrations cause constant motion improving the connectivity between different brain...
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Risk Management Process for Medical Devices
Risk Management in Medical Devices is a complex process and requires a strategic approach requiring careful analysis of steps involved in the manufacturing process. ISO 14971 requires specific practices meant for strategically implementing risk management...
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5 Easy Steps of Change Management Process for Medical Devices
Change is an essential part of the Medical Device Development Process. Every successful Medical Device starts from a naïve idea that undergoes very rigorous processing to come out as a successful medical device serving an exact purpose. A Medical Device...
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What is Design History File? Why it is Important for Medical Device Development
Medical Device Development is a multilevel process. Each step needs strict monitoring and documentation. But why document everything? Is it just because Medical Devices deal with human lives? Yes, it is! Not only it is a necessary practice for end-user’s...
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Transforming lives of patients in South India with Artificial Intelligence based diagnostic device
The success of the Medical Device depends on the level of impact it creates. With an ever-growing population, the need for accessible, accurate, and affordable diagnostics is increasing. Here we discuss how AI-based Diagnostic devices make lives easier and...
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Optical Imaging Medical Device Manufacturing Services
The Medical Imaging Market was USD 36.19 billion in 2020 and it is estimated reach USD 56.53 billion by 2028, exhibiting a CAGR of 5.8%. The optical imaging market on the other hand will reach USD 3.3 billion by 2026 from USD 1.6 billion in 2021 at a CAGR...
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Significance of Lean Six Sigma in Medical Device Manufacturing
Every organization works with a set of processes that require continuous nurturing and update for maximum productivity. It's necessary to align efforts in the right direction to ensure higher productivity, optimized cost and minimal waste. Implementation...
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