Complianzworld | Online Training & web Seminar

Global Medical Device Regulations: US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan: One and a Half-day In-person Seminar

Date:Jul 24-25, 2014 09:00 AM ETD | 05:00 PM ETD

Location: San Diego

Seminar Course Description:

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 the 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

The following personnel will benefit from the course:

• 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!

Reasons to Attend: • In this One and a Half-day In-person Seminar the trainer will walk you through to get

familiar with the medical device regulations in the following twelve (12) countries.US• EU• Canada• Argentina• Australia• Brazil• India• Japan• Mexico• Russia• South Korea• Taiwan This workshop is intended to provide guidance on medical device classification and

registration requirements in these countries.

Seminar Agenda Day:1

8:30am – 9:00am - Registrations

9:00 AM – 10:30 AM: •

Medical Device Regulations in US and Canada 

10:30 AM – 10:40 AM: Break

10:40 AM – 12:00 Noon • 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• 12:00 Noon – 1:00 PM: Lunch

1:00 PM – 2:30 PM•

Medical Device Regulations in Argentina, Australia, Brazil, India, and Japan

2:30 PM – 2:40 PM: Break

2:40 PM – 4:00 PMMedical Device Regulations in Mexico, Russia, South Korea, and Taiwan

Seminar Agenda Day:2

8:30 AM – 10:00 AM• ISO 13485• ISO 14971• ISO 14155• GHTF documents

10:00 AM – 10:10 AM: Break 

10:10 AM – 12:00 Noon• MEDDEV guidance documents• Clinical investigation• Adverse event reporting

Register Online

• $ 1399$ 1599Seminar - Single registration (Earlybird Price) *Earlybird price is valid till Jun-30-2014

• Jul 24-25, 2014, San Diego• $ 6396

$ 7995You Save: $ 1599(20.00%)*

• Special - Group Discount; Register for 5 attendees Jul 24-25, 2014, San Diego

• *Hurry! This option is limited and based on availability. Great savings on Group

Seminar Venue:

Easily Downloadable Brochure

Speaker Profile