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Biomedical Technology Tips & Techniques

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Biomedical Technology Tips & Techniques

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includes 81 issues of the bimonthly magazine

March 2003 to December 2016

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January-February 2017

 

Medical Plastic Data Service

 
24th Year of Publication 

 

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Content Overview: January - February 2017

Cover Story

Cover Story : Event Highlights

14th National Conference & Technology Exhibition on “Indian Medical Devices & Plastics Disposables/Implants Industry 2017” supported by major leading industry associations as well as Government, Regulatory, Export Promotion and Research Organizations.
Conference Theme : “Manufacturing Medical Devices in India : Growth Opportunities”
Highlights :

1. “Regulatory Issues: Current Status and Strategies”
2. “Innovate In India”
3. “Indian Medical Device Industry : Moving Up Value Chain”
Session Themes :

1. Developments in Materials & Processes to Facilitate Growth.
2. Drug / Device Combination Products & Implants : Definition & Technological Challenges, Market Overview.
3. Drug / Device Combination Products & Implants : Regulatory Challenges & Requirements, Clinical Trial Requirements, Innovations and New Developments.
4. Medical Plastics : Materials, Processes & Markets
Workshops :
1. Technology Driven Transactions : Skill Development Workshop For Business Owners
2. Biocompatibility Training : Updated Information, Clarifications and Recent Advancements
Student Program :
1. Participation in Technological Conference.
2. Introduction to Career Opportunities in the Medical Technology Industry.
3. Opportunity for poster Presentation in the Technology Show Exhibition.
4. Paper and Poster Presentation Competitions for Students evaluated by Industry Experts.
AMTZ Investor’s Meet
AiMeD Members Meet

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Roadmap for Indian Medical Device Industry
Shri Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) And Jt. Managing Director, Hindustan Syringes & Medical Devices Limited, Faridabad.
“AiMeD has submitted a defined roadmap and task list with Department of Industrial Policy & Promotion (DIPP) and Department of Personnel (DOP) to enable ‘Make in India”

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Indian Medical Device Industry to Develop Into A Global Manufacturing Hub
Shri Kishore Khanna, Managing Director, Romsons Group of Industries, Agra
“Indian medical device industry is consolidating with the introduction of several steps initiated by the Indian government to broaden the medical device manufacturing base and to enhance exports from India”

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Quality

Advanced Process Validation For Medical Device Manufacturers

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Industry News

  • AiMeD & Invest India sign a momentous MoU aimed at making India a global manufacturing hub for medical devices and components

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Did You Know?
 

About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials
 

FDA’s Center for Devices and Radiological Health (CDRH) has identified “Modernizing biocompatibility and biological risk evaluation of device materials” as one of the CDRH’s top ten regulatory science priorities for FY2017. The regulatory science priorities serve as a guide for making strategic intramural research funding decisions to ensure that CDRH research is focused on needs that are relevant and critical to medical devices and radiation-emitting products.

 

To determine the safety profile of implantable or patient-contacting medical devices, it is critical to perform biocompatibility evaluation to assess the risk of adverse events. This helps us understand and address the risks posed by the potential presence of harmful chemicals or immune response triggers such as contaminants, manufacturing materials, residues and byproducts as well as device degradation byproducts.

 

While animal studies have historically been used to predict long-term safety and effectiveness, tests for carcinogenicity, reproductive toxicity and systemic toxicity are expensive, time consuming, use large numbers of animals and sometimes do not provide results that are easily translatable into a human risk assessment. New, less burdensome approaches that are more patient-centric and predictive of realworld device performance are needed to modernize and transform biocompatibility evaluation of medical devices and their materials. The biocompatibility review of device materials could be further enhanced by developing acceptance criteria, which could include multidisciplinary evidence obtained from integrating chemical characterization, computational modeling, device surveillance and emerging risk assessment tools. Modernizing biocompatibility and biological risk evaluation will reduce healthcare costs and patients would have access to safer devices faster.

 

(Ref: More details at : http://www.fda.gov/downloads/MedicalDevices/
ScienceandResearch/UCM521503.pdf).

 

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From the Archives...

Global Trends

Did You Know? Industry News

About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials

FDA’s Center for Devices and Radiological Health (CDRH) has identified “Modernizing biocompatibility and biological risk evaluation of device materials” as one of the CDRH’s top ten regulatory science priorities for FY2017. The regulatory science priorities serve as a guide for making strategic intramural research funding decisions to ensure that CDRH research is focused on needs that are relevant and critical to medical devices and radiation-emitting products....
  • Medical Devices Industry Wants Govt To Create Investor - Friendly Environment
  • Medical Device Industry Rules Recommendations Not Incorporated In The Draft For New Medical Device Rules
  • AIDCOC Urges Health Ministry To Empower State Licensing Authorities (SLAs) To Grant License To Critical Medical Devices
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