“Blood is not ketchup! Biocompatible Plastics for Medical Devices”

Individual medical care with increased life expectancy, is a challenge today. Let us make durable medical devices to support the billions. Covestro High Performance Polycarbonate is a proven choice with 50 years of Makrolon in the global medical  market. We enhance design freedom by weight reduction, heat resistance, toughness & transparency.

"Improving Quality, Efficiency and Compliance with Paperless Manufacturing (Manufacturing Execution Systems)"

Challenges have been constantly increasing for Medical Device Manufacturers to produce a high quality product with regulatory compliance. Global demand has been putting high pressure on the manufacturers to release the new products in short  time. Regulatory authorities have been releasing and enforcing the stringent regulations for the processes, validations, documentation and record retention requirements.

• Generate instantly Electronic Device (eDHR) and/ Batch History Records (eBHR) and Retain them throughout the life cycle of the product

• Improve your bottom line with Manufacturing Operations Management coupled with Supplier Quality and Post Market Surveillance from FDA

• Reduce your Validation time and Time-to-Market for New Products

"Styrenics solution for Infusion system, Fluid delivery, Respiratory & Drug device"

Styrenic polymers ( Novodur ® HD ABS, Luran ® HD SAN, NAS ®SMMA, Styrolux ®SBC, Styroflex ®SBC, Zylar ®MBS & Terlux ® MABS) are suitable for medical device application with regulatory compliances. These styrenic products have been  long used for major medical device applications, such as Infusion set connectors, adaptors, Stop cock, Valves, Drip Chamber, Infusion tubes, DPI inhalers, Airways, nebulizer housing,face masks & respiratory filters. Edical grade styrencis Products are designed to replace PVC & PC for producing medical devices products infusion systems & respiratory device applications. This presentation describes specially opaque & transparent medical grade polymers in infusion system (Fluid delivery) and respiratory (drug delivery) device. Our bio-compatible styrenic products have good processing, high impact strength, surface quality, dimensional stability, high gloss appearance, high stiffness, scratch resistance, resistance to fluctuating temperature & excellent resistance to chemicals. The regulatory compliance of our Styrenics are, USP Class VI, ISO- 10993, DMF registration, EUP, JP, Regulation (EU) No.10/2011 statement and FDA (US) statement.

"Career Opportunities for Medical Device Software Development"

Changing global economic cycles have created a lot of disturbance in global supply chain as well as in job market. This forces students to look at career alternatives, as conventional IT opportunities dries up. Safety critical industries like Medical devices creates a value added engineering skills based career opportunity for students. Even though a safety critical product development involves requirement analysis, design, development, testing & certification, the last two consumes more time and money. This forces global players to outsource testing to countries like India. But lack of skills in international safety & security standards in India, becomes a major bottleneck for students getting into this area. This paper would discuss career opportunities as well as how students and faculties can be prepared to grab these opportunities.

Safety And Risk Management For Healthcare Professionals

In this talk, I will briefly introduce you to the following topics which can be very useful for healthcare professionals in daily routine practices.

• Integrating Employee & Patient Safety

• Healthcare Stress Management

• Managing SUD’s in Hospital

• Critical Care Equipment Cleaning Protocol

• Patient Medical Device Management

• Management of NSI / Blood or Body Fluid Exposure & Significant of Vaccination

• Hospital Cleaning or Sterilization Protocol

• Hospital Acquired Infection