Tag: AMTZ

INTERNAL AUDITOR TRAINING PROGRAM

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Internal Auditor Training Program As Per Iso 13485:2016 Standard

IBSC (Indian Biomedical Skill Consortium) is conducting Internal Auditor Training Program on ISO 13485:2016 – Medical Device Quality Management System

COURSE OUTCOMES:

a. Use of ISO13485:2016 as the basis for a QMS for medical device manufacturers
b. Ways to increase effective manufacturing of medical devices and cost savings through quality management
c. Supply chain monitoring to achieve continuous improvement·  
d. Understanding how to meet regulatory requirements leading to increased patient safety

Duration: 3 Days (12th, 13th & 14th October 2023)
Mode: Online (Hybrid mode)
Eligibility: Any (Working Professionals & Interested Student

Discount: 25% to AMTZ Manufactures; AiMeD Members, IBSC Partners
For quotation send email to n.nareshkumar@ibsc-amtz.in

Program Details: https://www.ibsc-amtz.in/coursedetails/30

Last Date for Registration: 7th October 2023

For more information, please contact :
Mr. Nitturi Naresh Kumar
WhatsApp: 918897330990
n.nareshkumar@ibsc-amtz.in

Certification Schemes from AMTZ 

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Program on Healthcare Textiles Processing Facility Certification Scheme and Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme 

Program on Healthcare Textiles Processing Facility Certification Scheme  

The scheme aims to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities that process them. Scheme covers Multiple-use healthcare Textiles to be processed only as Single-use healthcare Textiles are not meant to be used again.   

Program on Biomedical Equipment Maintenance Certification (BEMC) Scheme    This voluntary scheme applies to maintenance process certification including Testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis.

This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider.  

These voluntary schemes are an initiative of AMTZ, in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI).


Date: 27th May 2023

Time: 3:00 pm to 6:00pm IST

Mode – Virtual Mode / Webinar
Program Agenda
Click here to Register

Workshop by IBSC – AMTZ

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Workshop on Indian Medical Device Regulations

IBSC – AMTZ is organising a Workshop on Indian Medical Device Regulations

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
  • To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices.

COURSE AGENDA

  • Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
  • Classification of Medical Devices
  • Basic Requirements
  • Content Requirements for Technical Documentation
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

  • Medical device manufacturers
  • Consultants 
  • Regulatory Affairs Specialists
  • Expert advisors in medical devices regulatory affairs
  • Working biomedical engineers / medical device professionals
  • Pursuing Students are also eligible

Fee: INR 3,540 including 18% GST

CANDIDATES WILL BE PROVIDED WITH IBSC CERTIFICATE


LAST DATE FOR REGISTRATION: 30th May 2023 


TRAINING DURATION: 2 DAYS (9th & 10th June 2023)


LOCATION: Faculty of Pharmacy, MS Ramaiah University of Applied Sciences, Bangalore 

For more information, please contact

Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990 | +91-7075737284
WhatsApp Link: https://wa.me/918897330990
WhatsApp Link: https://wa.me/917075737284
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

Launch of Healthcare textiles processing facility certification Scheme

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Healthcare Textiles Processing Facility Certification Scheme Launched in India

On the occasion of World Health Day on 7 April, the triple A partnership of AMTZ LTD, Association of Healthcare Providers – AHPI (India) and Association of Indian Medical Device Industry – Aimed India, launched Healthcare Textiles Processing Facility Certification Scheme (HTPFCS) to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities or laundries that process them for reuse

While the Covid-19 pandemic has highlighted the importance of healthcare textiles and PPE in protecting healthcare workers and patients from infection, the quality of these products depends not only on the materials used but also on the processing facilities where they are sterilized, cleaned, and packaged.

The Healthcare Textiles Processing Facility Certification Scheme will help ensure that these facilities meet international standards for quality and safety. It aligns with international standards and guidelines, including those of the World Health Organization (WHO) and the International Organization for Standardization (ISO).

Under the scheme, healthcare textiles processing facilities can apply for certification by undergoing a rigorous evaluation process that includes site visits, documentation reviews, and testing of samples.The certification will be valid for three years, after which the facility will need to undergo a recertification process.

The Certification would be carried out by independent third party certifying agencies to be accredited as per applicable international standard, ISO 17065, and approved by AMTZ to assure their competence, impartiality and consistent implementation of certification process.

The Healthcare Textiles Processing Facility Certification Scheme is open for applications from healthcare textiles processing facilities in India and abroad.

source:http://www.pharmabiz.com/NewsDetails.aspx?aid=157437&sid=1#:~:text=The%20Healthcare%20Textiles%20Processing%20Facility%20Certification%20Scheme%20is%20a%20welcome,of%20healthcare%20textiles%20and%20PPE.

WORKSHOP ON INDIAN MEDICAL DEVICE REGULATIONS

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Workshop on Indian Medical Device Rules 2017

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices.

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
  • To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices

COURSE AGENDA

  • Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
  • Classification of Medical Devices
  • Basic Requirements
  • Content Requirements for Technical Documentation
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

  • Medical device manufacturers
  • Consultants 
  • Regulatory Affairs Specialists
  • Expert advisors in medical devices regulatory affairs
  • Working biomedical engineers / medical device professionals
  • Pursuing Students are also eligible

Duration: 2 Days (31st March & 1st April)

Location: Kalam Convention Center, AMTZ Campus, Vizag

Fee: INR 3,540 (Including GST)

Registration link: https://ibsc-amtz.in/coursedetails/25

Last Date For Registration: 25th March 2023
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For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990
WhatsApp Link: https://wa.me/918897330990
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

Admission Open – Online Learning

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Call for Admissions – Online Skill Training Program on “Certificate in Biomedical Quality Assurance”

Call for Admissions – Online Skill Training Program on “Certificate in Biomedical Quality Assurance” 8th Batch starts from 18th March 2023. (NSDA Approved Course; Job Role No: 2019/HLT/AMTZ/3578)

Duration: 3 Months / 50 Hours (Online Lectures by Industry Experts – Saturday)

Sessions on Every Saturday 06:00 PM – 09:00 PM

Training Modules:
1) Global MDR
2) Indian MDR – 2017
3) USFDA
4) CE Certification
5) ISO 14971:2019
6) ISO 13485:2016
7) MDSAP

For Registrations, eligibility, application process & discounts please visit:

https://ibsc-amtz.in/coursedetails/10

Last Date for Registration 11th March
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For more information please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in

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