FMDIC Public Workshop – June 15

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Medical Device Reporting, Complaints, and Recalls, Corrections, and Removals

Presented by the FDA Medical Device Industry Coalition

Are you troubled by what you see in the news? Have you struggled with how to handle complaints from your users while maintaining Regulatory Compliance?  Do you often wonder about what is reportable to the FDA? Do you feel prepared if you had to conduct a recall today? If any of these topics strike a chord, then plant to attend this educational forum to develop effective proactive strategies!

In a joint presentation by FDA, industry and academia, this workshop will provide critical information about FDA’s medical device regulations to the regulated industry and is tailored to small businesses, with an opportunity for Q&A with a panel of knowledgeable experts.  Topics include:

  1. Medical Device Reporting (MDR),
  2. The Role of Complaint Files,
  3. Recalls, Corrections, and Removals, and
  4. Corrective and Preventive Actions (CAPA) as it applies to complaints.

Date and Time:                                     Friday, June 15, 2012, 8 a.m. – 5 p.m.

Location:                                               Renaissance Dallas Hotel, 2222 Stemmons Freeway, Dallas, Texas, 75207.                                                                  http://www.marriott.com/hotels/maps/travel/dalbr-renaissance-dallas-hotel/

Registration: Register online using Visa, MasterCard, or American Express and secure your seat right now.

Registration Type

Early Registration Fee before 6/1/2012

Regular Registration Fee until 6/15/2012

General

$250

$300

Government with ID

$150

$200

Student with ID

$50

$75

For additional details on the event, please go to http://fmdic.org/events-training/mdr-complaints-recalls/  or contact David Arvelo, FDA, at  david.arvelo@fda.hhs.gov.

NOTE:  These workshops are very popular and registration is limited.  Be sure to sign up early to avoid being disappointed!  On-site registration will be available starting at 7:30 a.m. the day of the event. 

Notified Body Audits Are Changing

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News from the Medical Device Notified Body Meeting in Brussels:

 

Notified Bodies are being advised to use their existing authority to conduct more unannounced inspection visits to manufacturers, conduct product sampling, witness device testing during audits, and perform market surveillance. Guidance is expected to be developed and issued to Notified Bodies on these practices soon.

FDA ISO 13485 Voluntary Audit Report Submission

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FDA CDRH is kicking off their ISO 13485:2003 Voluntary Audit Report Submission Pilot Program June 5, 2012.  FDA wants to explore how they can leverage off of some of the ISO 13485 audits being conducted by ISO conformity assessment bodies.

The premise of the 13485 Voluntary Audit Report Submission Program was based on an amendment to the law, which is in Section 228 of the FDA Amendment, and it basically tells FDA that they can accept voluntary submissions of ISO reports for purposes of setting risk-based inspectional priorities.  With a satisfactory audit report indicating a manufacturer’s Quality System is acceptable,  FDA could utilize this information for risk-based work load planning for determining where to take their resources for inspections.

MDM Showcase

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OMEDtech exhibited at the MDM Texas Exposition and Showcase in Fort Worth on March 14 & 15.  OMEDtech and Tietronix shared a booth showcasing QMS development and management.

Welcome to Our New Website

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In 2002 David Makanani and Steve Ford, saw an opportunity to use their over 60+ years of combined experience in medical device development, to help companies successfully create products, move swiftly and accurately through the regulatory process and achieve market introduction in the shortest amount of time. OMEDtech was founded in that year to provide a resource with a proven track record of success to assist your company in meeting its product development goals.