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Discussing Compliance Audit Management Trends and Best Practices to Meet Local, International Regulations and Notified Body Expectations
Given that the malfunction of a device can lead to a fatality, there is a crucial need to ensure that these devices are safe and are monitored effectively. Any complaints on devices need to be monitored so that if there is a need to recall the device, it can be done efficiently without any further impact to patients. One of the biggest challenges for many medical device manufacturers is the ability to collect data from different sources such as hospitals, doctors and patients. In addition, the various regulations tied to the medical device safety industry elevate the need to audit compliance programs.
Marcelo Trevino weighs in on the various international regulations and audits in the medical device industry this January in Las Vegas at the 2nd Annual Medical Device Safety Monitoring and Reporting Conference. Marcelo shares his thoughts on maintaining compliance.
How do you best prepare for internal and external compliance audits? How do you demonstrate your organization has a quality system in place to ensure safety and effectiveness of a medical device?
Being prepared for a compliance audit is extremely important. Auditors or Regulators will look at quality systems to establish if the devices that are being manufactured are safe and effective. Preparing ahead of time is important and here are several key items to keep in mind:
Are there any best practices or useful tips when preparing for FDA Audits?
There are many best practices that can be utilized by organizations preparing for an FDA Audit. Some include asking the following questions and ensuring you are ready to clearly answer and provide objective evidence:
Your session delves into the differences between CMDR, Japan PAL, EN ISO 14971, MDD, Brazil ANVISA and Australia TGA Audit. What would you say is the key take away from this particular topic?
In a global and complex medical device world it is important to have the following things in place in order to be able to compete and successfully commercialize products locally and internationally. The following should be considered:
For more information, please visit 2nd Annual Medical Device Safety Monitoring & Reporting Conference or contact Michelle Thomas, Marketing Coordinator, Media & PR, marcus evans at 312-540-3000 ext 6491 or email@example.com
About marcus evans
Marcus evans conferences annually produce over 2,000 high quality events designed to provide key strategic business information, best practice and networking opportunities for senior industry decisionmakers. Our global reach is utilized to attract over 30,000 speakers annually; ensuring niche focused subject matter presented directly by practitioners and a diversity of information to assist our clients in adopting best practice in all business disciplines.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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evans, marcus. "2nd Annual Medical Device Safety Monitoring & Reporting Conference, January 22-23, 2014, Las Vegas." Medical News Today. MediLexicon, Intl., 13 Dec. 2013. Web.
25 Apr. 2014. <http://www.medicalnewstoday.com/releases/270123>
evans, M. (2013, December 13). "2nd Annual Medical Device Safety Monitoring & Reporting Conference, January 22-23, 2014, Las Vegas." Medical News Today. Retrieved from
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