Medical Device Quality Systems Solutions
Adam Metzger
Consultant
Extremely capable, data-driven, analytical, and solutions oriented quality systems expert with over twenty years’ experience in the medical device manufacturing arena. Experienced with quality system restructuring, systemic change control compliance, process harmonization, preparing and maintaining procedures from both internal and external compliance perspective, supporting audits as a certified lead auditor, subject matter expert, and backroom resource. Experienced in NCR, CAPA, MRB, complaint investigations, and root cause analysis. Well versed in FDA regulations (21 CFR 820), Good Manufacturing Practices, ISO 13485, ISO 9001, MDD, MD SAP, and EU MDR.
Verushka Metzger
Consultant
Industrial Engineer and Quality System expert with over 20 years of experience in the Medical Device Industry. Skillful in compliant, consistent interpretation and implementation of medical device regulations and standards. Expert in performing gap assessments, designing effective solutions and ensuring audit readiness. Proficient in CAPA, Design Controls, Complaints, Escalations, Purchasing Controls, Non-Conforming Product, Document Control, Production and Process Controls and Risk Analysis. Strong background in manufacturing and quality engineering, experienced in process improvements, root cause analysis and validations. Solid interpersonal, oral and written skills. Successful in influencing, mentoring, training and leading people and projects. Fluent in Spanish and English.
Specialties: EU MDR, ISO 13485:2016, FDA 21 CFR 820, Gap Assessments, six sigma, Lean Manufacturing, Project Engineering, CAPA, QRB, Quality Engineering, Validations (IQ, OQ and PQ), Software Validations, Remediation of records (CAPA, complaint, design history file and technical file documents including design verification and validation), auditing, technical writing, technical files, complaints management, development/improvement of procedures and training, Process Optimization via Scientific Molding, Industrial Statistics, Quality Systems. Power user in a variety of systems: Windchill, Agile, Adaptive, EpiCenter, cPDM, TrackWise, EtQ.
Services
MDQSS focuses on relationships with our clients, then providing exceptional consulting services that are catered specifically to their needs. Check out a few areas of our expertise below.
Quality Systems Remediation, Optimization & Audit Readiness
MDQSS solves quality and compliance issues by developing and implementing comprehensive solutions that are conforming to applicable standards and regulations. We are experts at reviewing and updating Quality System processes and documentation to ensure compliance. Contact us to find out how we can help today.
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Document and Change Control
We are experts in best practices that medical device companies need to understand and follow when making changes to documents, products, processes, and more.  Contact us to find out how MDQSS can help today.
Non-Conformances, CAPA, Complaints, Validations
We are experts in root cause investigations, remediations, validation protocols and reports.
FDA/ISO/ EU MDR Internal Audits
If you have internal audits aproaching and find your team's time is stretched thin, let MDQSS help. Our experts are ready to assist your organization achieve and maintain compliance to ISO, CFR 820 and EU MDR.
Project Management
Our services are customized to meet the specific needs of each client. I work collaboratively throughout the entire process and guarantee measurable results. Contact me to find out how I can help today.
EU MDR Technical Documentation and Notified Body Submissions Support
Our team of experts can help your organization with preparing or reviewing documentation for EU MDR technical files, as well as, providing support with Notified Body submissions and questions on the submitted EU MDR technical file documentation.