Despite the name, Wicked QMS takes quality assurance and regulatory compliance very seriously. Why the name? The intent is to be memorable, something different, and just maybe, a tiny bit light-hearted. In short, it is to show that you can be seriously passionate about something as basic as quality assurance and regulatory compliance and yet enjoy it too. Wicked QMS is the next step in a quality management system (QMS) consulting practice started by Richard Welch in 2011. Since that time he has helped multiple firms establish, implement, and maintain a simple but robust QMS compliant to domestic and international regulatory authority requirements within the medical device industry. A QMS should have as few operating procedures and work instructions as necessary. When properly implemented, a QMS becomes a seamless and almost transparent part of a firm’s business model. And, when that happens …”there’s nuthin’ wicked about it!”
Richard has almost 30 years’ experience within the medical device industry (Class I, Class II, Class III devices), more than sixteen years of which are in supervisory and leadership positions taking twenty-three plus devices from concept to commercialization. Throughout, he has held positions of increasing responsibility in the areas of Manufacturing Engineering, Document Control, Research & Development, Quality Engineering, Post Production Vigilance (Complaint Handling), and Regulatory Compliance while providing fundamental direction and guidance around the interpretation and implementation of both domestic and international medical device regulations, directives, and standards. It is this experience along with a broad knowledge of domestic and international QMS requirements that allows him to value more fully the oftentimes contrasting needs of a firm’s diverse stakeholders.
Richard has successfully developed, implemented, and maintained transnational multi-site quality management systems compliant to MDD 93/42/EEC, CMDR SOR/98-282, ISO13485, German Medical Devices Act, and 21 CFR Part 820 as well as obtaining and maintaining both European and Canadian ISO13485 quality system site certifications. This has included the primary development of systems for ongoing clean room certification and environmental monitoring; sterilization dose mapping, validation, and quarterly dose audits; packaging validation (both performance and stability testing); device chemical characterization and biocompatibility; bacterial endotoxins testing; adverse event and incident reporting (MDR and MDV); recalls and field safety corrective actions (FSCA); equipment maintenance and calibration; as well as purchasing controls for supplier quality such as supplier evaluation, supplier change control, specification development, buying and planning, receiving and inspection, and supplier corrective action.
Richard has considerable startup and established organization experience with up to 64 direct and indirect reports. He has functioned as the Management Representative and primary interface for regulatory authority communication, internal and external audits, as well as the scheduling and leading of management reviews. Additionally, he has supervised and managed purchasing, quality engineering, quality control, receiving and inspection, document control, as well as complaint handling and returned product investigation operations. He has experience demonstrating medical electrical equipment compliance to general requirements for basic safety and essential performance (IEC 60601-1 3rd ed.), usability engineering (IEC 60601-1-6, EN 62366), and software lifecycle development (EN 62304). He has also held responsibility to obtain and uphold facility registrations for multiple notified bodies (NSAI, DQS, BSi, SGS), the California Food & Drug Branch, Health Canada, and the US Food and Drug Administration.
Richard has substantial experience in the review and approval of labeling, operating procedures, design description documents, advertising and promotional literature, website materials and publications, validation protocols and reports (IQ, OQ, PQ, test method, packaging), investigator brochures, and clinical investigation plans. He has led, managed, and implemented corrective actions and follow-up communications relevant to Food and Drug Administration (FDA) form 483 observations/findings, complaint handling transformation and remediation activities, Food and Drug Administration (FDA) requests for additional information, and multiple and concurrent domestic and international recalls and field safety corrective actions (FSCA). He has also led organizational activities around conformance to OSHA requirements for blood borne pathogens and promoted activities for hazard communication, injury and illness prevention, and emergency evacuation.
To learn more about Richard’s experience and work history, click here.