December 18, 2013
Medtronic Interview with Marcelo Trevino: Medical Device Safety Monitoring & Reporting Conference
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 manymedical 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:
- Train personnel on the quality system regulations and standards; be prepared to customize presentations and information in order to meet expectations of international regulators.
- Evaluate risks and changes impacting the quality system
- Verify Effectiveness of previous audit findings
- Organize CAPA/Non-Conformance Material Reports to clearly explain how deficiencies are handled.
- Demonstrate Management Support
- Ensure subject matter experts are trained and available during the audit.
- Prepare a front room and back room and define roles and responsibilities ahead of time
- Conduct Mock Audits.
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:
- Review Complaint Files, Assess if MDRs were submitted on time. What are the trends? Does the company trend data? How is this used? If electronic records are requested, evaluate what would be the best way to provide thisinformation to the investigators.
- Review Non Conformance System: What are the trends? How are the trends related to Complaints, product, design? Be prepared to explain links. Do these Non-Conformances escalate to CAPAs? Can you demonstrate defects can be identified through: Incoming inspection, Test method validations, statistical methods/sampling plans, finished goods testing, post market surveillance
- CAPA: How many are open? How many are closed? Were they addressed in a timely fashion? Are Root Cause Investigations adequate and effective? Were verifications or validations done correctly before closing the files? Does Company have System outside CAPA? Quality Goals, “Projects” Internal audits? I f so, be prepared to explain.
- Supplier Quality: What is the process, do we have good systems to qualify suppliers, are there SCARs open?
- Design and Production Changes: Are they in compliance with the regulations? Are process validations adequate?
- Internal audit: Is there a plan in place? Has the company adhered to the plan and covered all the elements of the quality system?
- Risk Management: Demonstrate ability to reduce risk. Do you reduce the level of defects? Do you improve detection? Can you reduce severity?
- Management Review Meetings: How frequently are they taking place? Is there an agenda, list of participants and list of Action Items from the meeting?
Have there been any major changes regarding regulatory compliance expectations from FDA?
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 t o 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:
- * Ensure a Culture of following procedures and send the right messages to your organization.
- Quality is everyone’s responsibility.
- Promote a culture of accountability, transparency, and timeliness.
- Are you fully understanding/evaluating quality and compliance risks in your decisions?
- Dig for the truth
* Constantly ask questions that will allow you to be prepared to meet globalquality requirements:
- * Are you getting transparency about compliance and quality issues?
* Alignment with International Regulations: Most of the requirements imposed by other countries are very similar but it is important to customize certain elements in the organization’s quality system in order to clearly demonstrate compliance and help regulators understand how you are meeting their expectations.
For more information, please contact Michelle Thomas, Marketing Coordinator, Media & PR, marcus evans at 312-540- 3000 ext 6491 or michellet@marcusevansch.com.
About Marcelo Trevin
Marcelo Trevino is an Experienced Quality & Regulatory Compliance Senior Manager with Medtronic in the Medtronic Heart Valves Center of Excellence/Cardiac & Vascular Group. Marcelo manages Quality Systems implementation and Regulatory Compliance for the Heart Valve manufacturing operations in Orange County, California.
Mr. Trevino has an extensive knowledge of Medical Device Management Systems:ISO 13485:2003 & International Medical Device Regulations: USA (FDA QSR), Australia (Therapeutic Goods, Medical Devices Regulations), Canada (SOR/98-282 & Canadian Medical Devices Conformity Assessment System (CMDCAS), Japan (Pharmaceutical Affairs Law), Europe (93/42/EEC Medical Device Directives).
He holds a Bachelor of Science in Indu strial an d Systems Engineering from ITESM in Mexico and an MBA in Supply Chain Management from the W.P Carey School of Business at Arizona State University. He is also a certified QMS Auditor by the Registrar Accreditation Board and has consulted with several corporate executives in medical device firms to implement different process and quality improvement projects.
Marcelo has conducted Third Party Audits for several Notified Bodies and has written several articles to assist corporations in their quest for quality and service excellence. Marcelo is a Certified Six Sigma Black Belt and Biomedical Auditor through the American Society for Quality (ASQ). He has experience working on Lean Six Sigma Projects and Quality/Regulatory Compliance with many medical device companies in the United States and around the world. Most recently he participated in the development of ASQ’s Biomedical Auditor Certification restructuring the Body of Knowledge and exam questions.
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 decision-makers. 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.
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