Medical Device Single Audit Program for Compliance Success (MDSAP) 2017 before 30 April 50% Discount

  • 1295.00 Dollar US$
  • Published date: March 24, 2017
  • Modified date: April 24, 2017
    • Boston, MA, Boston, MA, United States

Reviewing the most significant changes affecting medical device standards and guidance documents
Understanding the MDSAP (goals and strategy)
Analyzing the MDSAP main differences with standard auditing
Understanding grading of MDSAP non-conformances
Assessing MDSAP Audit structure and reporting to regulators
More than six Notified Bodies are in the Pilot Program, Office audits and witnessed audits are required (conducted by regulators)
And Much More...
Why should you attend:

Clear Understanding of MDSAP objectives, approach and the overall process
Develop, manage, and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions
To promote greater alignment of regulatory approaches and technical requirements
To promote consistency, predictability, and transparency of regulatory programs
What is MDSAP?
How MDSAP Works?
How does MDSAP fit with other certifications?
MDSAP Status
Beneficial to manufacturers of medical devices who are interested in marketing and selling devices in those countries (Regulatory Authorities)
Next Steps in 2017 and going forward?
Areas Covered in the Session:

International partners that are participating in the MDSAP Pilot include US FDA, Therapeutic Goods Administration of Australia, Brazil's Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan's Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program and the European Union (EU) are Official Observers
MDSAP Guidance Documents
Regulatory Authorities (RA's)
Auditing Organizations (AO's)
Audit criteria of the MDSAP program will include the requirements of ISO 13485 and the applicable requirements of the participating regulatory authorities
MDSAP Processes and Audit Sequence

Location: Boston, MA Date: May 4th & 5th, 2017and Time: 9:00 AM to 6:00 PM

Venue: Embassy Suites Boston Logan Airport
Address: Embassy Suites Boston Logan Airport 207 Porter St, Boston, MA 02128, USA

Price:

Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until March 31, Early Bird Price: $1,295.00 From April 01 to May 02, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

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