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
HOSPEX Healthcare Expo cum Conferences 2023 – SEP 15-17,2023 at Zamra International Convention Centre, Kochi, Kerala
The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.
Experience the Next Generation of Healthcare at HOSPEX Healthcare Expo in Kerala! Join us as we bring together leading manufacturers and suppliers from the medical industry to showcase cutting-edge medical equipment and innovations. From state-of-the-art imaging technology to advanced surgical instruments, explore the latest advancements that are shaping the future of healthcare.
2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi, Kerala.
HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.
Expo cum Conference Theme this year is on :
Future of Healthcare – Device | Digital | Diagnostics
Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.
HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry.
HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.
The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.
SMART Hospitals Conference
Date : Sep 16, 2023
Time : 10 00 am to 6 00 pm
Fee : Rs 500 per delegate
SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.
Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.
Conference Outline :
SMART Medical Technologies help Practitioners to improve service standards
SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
SMART Prescription for Prescribers – EHR Solution
SMART Technologies to enable Small Hospitals – Technology Session
SMART HealthTech Ecosystem
Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
Smart Healthy Aging Tech Solutions
Target Audience :
Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc
HOSPEX PURCHASE MANAGERS WORKSHOP – FOR BIOMEDICAL TEAMS, PROCUREMENTS TEAMS IN HOSPITALS AND OTHER HEALTHCARE SETTINGS
Venue: Zamra Convention Centre, Kochi, Kerala
Date : September 15, 2023
Time : 2 30 pm – 5 30 pm
Fee – Rs 250 + GST
Target Audience :
Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings
Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .
Workshop shall cover following items that Hospitals Procure with special reference to:
– Biomedical Equipments
– Consumables and Disposables
– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose
Program Objective :
Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)
Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :
Understanding Medical Device Regulations- Laws of the Land
Medical Device Regulations – Role of Bureau of Indian Standards
Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
Claims of Voluntary Certifications – How Authentic these claims are ?
Materiovigilance Program of India – Regulatory Requirement
DoP releases strategy document to fine tune & implement National Medical Devices Policy
In an effort to fine tune and proceed with the implementation of the National Medical Devices Policy, 2023, launched in the month of May, the Department of Pharmaceuticals (DoP) has come out with an elaborate strategy document which emphasises on data security measures, adoption of national nomenclature for medical devices, a strategy to manage e-waste of obsolete medical devices and strengthening of technology transfer capabilities in the sector.
It would also work towards providing awareness to the innovatory community on regulator compliance, early on in the product development cycle through structured programmes using course curriculum, skill training or workshops, it said.
The NMDP, 2023 covers six broad areas of work for the promotion of the medical devices industry including regulatory streamlining, enabling infrastructures, facilitating research and development and innovation, attracting investments in the sector, human resource development and brand positioning and awareness creation.
As part of infrastructure development, the strategy document states, “”In close coordination with the ministry of environment, forest and climate changes, processes will be developed for e-waste management of obsolete medical devices”.
“The Policy strives to create an ecosystem to promote Research and Innovation in the sector under the ambit of the department’s proposed separate ‘Policy to Catalyse R&D and Innovation in the Pharma-MedTech Sector in India’”
Besides, a mechanism will be put in place to hand-hold the innovators and IP holders towards commercialisation of the products
Under the fiscal and non-fiscal measures to attract investments in the sector, it looks at incubation support for start ups in the R&D and innovation, mentorship for entrepreneurs along with skill development, such as business management, market access and commercialisation efforts for the innovation solutions developed, technology transfer mechanism for innovative solutions and relations for start-ups in compliance and regulatory regime.
Under the human resources development strategy, it envisages that since the human resources in the field of design are limited, the National Institutes of Design (NID) and private design schools will be encouraged to teach design centric courses to fill the gap, it added.
Commerce ministry authorises EPCMD to issue registration-cum-membership certificates for exporters
The Commerce Ministry has authorized the newly-established Export Promotion Council for Medical Devices (EPCMD) to issue registration-cum-membership certificates for exporters of specific medical items. These items include bandages, first-aid boxes, hot water bottles, ice bags, gloves, surgical garments, syringes, and stethoscopes.
A Registration-cum-Membership Certificate (RCMC) is required for exporters to avail benefits under the foreign trade policy, as well as customs and excise benefits
Holding the certificate can also help exporters in availing benefits with respect to customs and excise.
These items also include hot water bottles, ice bags, gloves, personal protective garments for surgical/medical use, surgical gowns and drapes, syringes, with or without needles, and stethoscopes.
The directorate general of foreign trade (DGFT) in a public notice stated that the council has been included in FTP for “issuing RCMC for specific items”.
BSI Antimicrobial Resistance (AMR) Certification – Launch event on Monday, 26th June 2023 between 15:00 hrs – 16:30hrs (IST)
According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.
Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics. Manufacturing waste from the production of antibiotics may contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled
BSI, in collaboration with the AMR Industry Alliance, will launch an industry antibiotic manufacturing certification scheme on 26 June 2023
This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to demonstrate evolving best practice and compliance to the Antibiotic Manufacturing Standard. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.
Companies including Centrient, Roche, Pfizer, Teva, Viatris, and Sandoz were participants in the pilot program and have helped provide technical expertise to shape the certification program.
Provide independent third-party assurance that your organization is minimizing the risk of waste emissions from manufacturing
Prove that the industry can self-regulate the antimicrobial resistance topic through certification and external third-party independent assessments
Differentiate yourselves in healthcare systems tenders by showing your antibiotic products are independently certified by a trusted organization with a recognizable Mark of Trust
Who should attend?
Pharmaceutical manufacturers
Regulators
Government policy makers
Trade associations
Contract manufacturers
Hospital / healthcare systems sustainability procurement
ESG metrics of IT services companies turn crucial in winning deals
For IT services companies, ESG (environmental, social, and corporate governance) metrics are becoming a crucial component in winning deals as clients are considering sustainability a top priority and are keen to work with partners who are on the same page.
“Sustainability is becoming an important part of the client’s evaluation. There is a tremendous focus across the world on sustainability, and it is becoming one of the top five business priorities. Organisations cannot become sustainable in isolation unless they have a complete ecosystem, including their partners, who are also sustainable. It is also becoming increasingly relevant for endusers,” said D D Mishra, senior director analyst, Gartner.
In a recent Gartner survey, more than half the end-users indicated that sustainability is a “must-have criterion” in the selection of service providers. End-users are also willing to pay extra to providers who can prove their strong sustainability commitment
Envirocare Green Awards is an initiative by Envirocare Labs started in 2018 with a vision to motivate and empower professionals & organization’s in the field of environment.
EGA is a non-commercial activity of self-motivated and like-minded people dedicated to making a positive difference to Sustainable Care.
The objective is to inspire stakeholders to think green & contribute towards a world that is not only progressive but also responsible towards its provider.
The applicants for these awards will be evaluated by an independent international Jury – renowned & respected in their professional fields. The award ceremony would be preceded by keynote speaker sessions.
The application for this award is online and is open for across the globe under the following categories:
The short listed applicants will be required to make online presentation for Jury evaluation. The data submitted would be confidential and used only for the purpose of EGA
Application deadline 15th June 2023, Please feel free to reach out to EGA Secretariat Ms Deenal Shah: +91 9167232025 | ega@envirocare.co.in
Program on Healthcare Textiles Processing Facility Certification SchemeandProgram 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.
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
