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Mike Begala - Senior Consultant, Quality Assurance & Regulatory Affairs

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Mike BegalaMike has more than 14 years of experience in the medical device arena. In his role with Emergo, Mike assists medical device clients with a variety of quality assurance issues including ISO 13485 and FDA Quality System Regulation (QSR) compliance, auditing and training. He is well versed in the quality system regulations of the United States, Canada and Europe, and how those regulations overlap and differ from one another.

In addition to his experience in the QA arena, Mike also has extensive experience with regulatory affairs issues including the preparation of European Technical Files and US FDA 510(k) applications. His extensive knowledge of biocompatibility testing, sterilization methods and packaging compliance is also very useful for clients with products for which this is an important regulatory compliance issue.

EXPERIENCE:

QA/RA Consultant, Maximum Business Advantage (2004-2005)
  • Quality systems consulting on ISO 9001, ISO 13485, FDA QSR and CMDR.
  • Process improvement and streamlining consulting.
  • Consulting on FDA cosmetic labeling regulations.

  • Internal and supplier quality audits for clients.

Senior Consultant, International Services Associates (2002-2004)
  • Independent consultant contracted with International Services Associates to provide Quality Management System consulting including auditing, training, procedure development, implementation and transition to ISO 9001:2000, ISO 13485:2003 and TS 16949 registration.
  • Led a team at the US Army Corps of Engineers to map and streamline procurement procedures.
  • Responsible for prospecting, selling and closing two new major implementation projects and several smaller accounts for Quality Management Systems consulting services.
Quality Assurance Engineer & Regulatory Affairs Coordinator, Atrion Medical Products (1994-2002)
  • Responsible for company-wide compliance with Food and Drug Administration's Quality System Regulation (QSR) and ISO 13485.
  • Performed internal quality system audits. Planned, coordinated, and followed up on the corrective actions for numerous internal and supplier quality audits.
  • Conducted company-wide training on the quality system, ISO and FDA requirements.
  • Implemented systems, procedures and training to achieve compliance with FDA's Drug Good Manufacturing Practice, CFR 210 and 211, for new drug labeling operations.
  • Set up new disposable contact lens packaging operation. Wrote procedures and provided training. Designed and implemented pouch seal validations.
  • Responsible for gamma radiation, ethylene oxide sterilization validations and biocompatibility testing.
  • Filed numerous FDA 510(k) Premarket Notifications, Technical Files and Design Dossiers.
  • Performed internal and supplier audits. Provided responses for FDA, Registrar and customer audits.
  • Designed plan for ISO 9001 and EN 46001 certification and coordinated the efforts of a ten-person implementation team. Successfully worked with all levels of the company, including upper management.
  • Established three-tier QA documentation system and wrote the Quality Manual, Quality System Procedures and Work Instructions.
  • Developed or aided in redesigning many new processes including Quality System Management Reviews, design control, document control, calibration, closed-loop corrective and preventive action system, archiving of quality records, internal quality audits and training.
  • Developed numerous inspection procedures. Knowledge of sampling inspection, including ANSI/ASQC Z 1.4 (MIL-STD 105E).
Chemist, North Water District Laboratories (1991-1994)
  • Supervised biochemical oxygen demand testing and conducted various laboratory operations

AREAS OF EXPERTISE:

Medical Devices:
  • Cardiovascular
  • Cosmetic/plastic surgery
  • Dental
  • Disposables
  • Ear, nose, throat
  • Gastroenterology/urology
  • Imaging equipment
  • Implants (non-active)
  • IVD
  • Mobility aids/equipment
  • Ophthalmic
  • Orthopedic
  • Patient monitoring
  • Prostheses
  • Radiology
  • Reusable instruments
  • Therapeutics
  • Software
  • Surgical instruments
QA & RA:
  • FDA Quality System Regulation (21 CFR Part 820)
  • ISO 13485:2003
  • ISO 14971:2007
  • Canadian Medical Device Regulations (CMDR)
  • Gamma and EtO sterilization validations
  • Internal auditing for QMS compliance
  • Preparation of a Technical File and supporting documents to obtain the CE Mark
  • Development of procedures for a Quality System compliant with FDA's Quality System Regulations, ISO 13485:2003
  • Training on US, Canadian and European medical device regulations

CERTIFICATIONS:

  • Certified Quality Auditor (CQA)

EDUCATION:

  • Bachelor of Science in Physics, University of Texas at Austin
  • Master of Science in Management, University of Alabama

HOME BASE:

  • Texas, USA