At this workshop, John Riggi (40+ years of experience) will walk you through to get familiar with the medical device regulations in the following twelve (12) countries.
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This workshop is intended to provide guidance on medical device classification and registration requirements in these countries.
During this workshop (1st day), medical device regulations of twelve countries will be discussed.
On the second day, we will discuss ISO 13485, ISO 14155, ISO 14971, GHTF documents, and MEDDEV guidance documents, etc. for quality and adverse event reporting including group discussions facilitating interpretation, understanding, and implementation of medical device regulations.
Why Should You Attend:
Understanding global medical device regulations and requirement and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.
At this workshop, you will get familiar with medical device regulations of twelve (12) countries concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices for adequate implementation and successful registration.
The following areas will be discussed during workshop:
- Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan
- In EU, the following four Directives will be discussed.
- DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
- DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
- DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
- DIRECTIVE 2007/47/EC Amending MDD and AIMDD
- ISO 13485
- ISO 14155
- ISO 14971
- GHTF documents
- MEDDEV guidance documents
- Clinical investigation
- Adverse event reporting
Who will Benefit:
This seminar will be valuable for anyone in the European Commission (EC) and FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those involved in research and product development, handling data and documents for regulatory submission for CE-marking purposes, conducting/monitoring/coordinating clinical investigation, and/or performing risk management and post-market vigilance/surveillance. This workshop is a must for those who are directly or indirectly involved in drafting and handling applications for CE marking purposes.
The following employees who will benefit include:
- Regulatory affairs (associates, specialists, managers, and directors)
- Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
- Research and development (associates, scientists, managers, directors and VPs)
- Product and development (associates, scientists, managers, directors and VPs)
- Contract research organization (associates, scientists, managers, directors and VPs)
- Site managers, and consultants
- Senior and executive management (VPs, SVPs, Presidents and CEOs)
- Contractors and subcontractors
- Anyone interested!
- 8:30 AM - 8:59 AM Registration Meet & Greet.
- Medical Device Regulations in US and Canada
- Medical Device Regulations in EU
- DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
- DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
- DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
- DIRECTIVE 2007/47/EC Amending MDD and AIMDD
- Medical Device Regulations in Argentina, Australia, Brazil, India, and Japan
- Medical Device Regulations in Mexico, Russia, South Korea, and Taiwan
- ISO 13485
- ISO 14971
- ISO 14155
- GHTF documents
- MEDDEV guidance documents
- Clinical investigation
- Adverse event reporting
John Riggi
President and CEO, Lake Ontario MED DEV Consultants
With over 40 years of experience in the medical device industry, Mr. Riggi’s success spans the following industry sectors:
- Ophthalmics
- Orthopedics
- High Volume Device Production
- Cardiac Rhythm Management
- Neurostimulation
- Infusion Technologies
- Medical and Dental Radiation Devices
Mr. Riggi brings this extensive experience to the client in the areas of:
- Global Quality Assurance/Regulatory Operations
- Global quality system development, implementation and assessment
- Client assistance during third party/regulator audits, inspections and assessments
- Medical Device Design Control
- Radiation safety
- Regulatory Compliance and Product Submissions
- Client assistance in registration dossier preparation
- Training on quality system regulations (US, EU, Canada, Brazil, China, Japan, Korea and Russia), MDSAP and EUMDR
- Corporate Compliance Assessment Programs
- ISO/CE Certification Processes
- Vendor Quality
- Enterprise Management System Leadership
- Regulatory/Notified Body Relationships
- Global medical device product registrations (US, EU, Canada, Brazil, China, Japan, Korea, Russia and numerous other jurisdictions in Latin America and Asia)
Whether on the manufacturing floor or in front of large conference audiences, Mr. Riggi’s open and relaxed communication talents ensure maximum value for the client.
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