Quality & Audit Services
Speaking, Training and Lecturing
Speaking in various events & organizations of various sizes, giving talks, participating in panels, running workshops & delivering training courses to quality teams, middle & senior management, and relevant stakeholders, all with great feedback. Our short workshops and longer courses, which can be tailored to fit the organization’s needs, provide a mix of topics with pragmatic tips & examples from the industry. Our speaking, training and lecturing subjects include: • General Quality Awareness Training for Medical Device companies employees • ISO-13485 Overview and Implementation • FDA Quality System Regulation (QSR) 21 CFR 820 Overview and Implementation • EU Medical Device Regulations (EU MDR) Overview and Implementation • The importance of Management Responsibility in Medical Device manufacturers • Supplier Quality and Controls • Internal and External Audits • Risk Management for Medical Devices • Medical Device Design Controls • Good Documentation Practice (GDP) • Defect Awareness Training per FDA QSR • Inspection Behavior Rules (Do’s and Don’t’s) • Corrective and Preventive Actions (CAPA) • Failure Investigation and Root Cause Analysis (RCA) Tools Selected examples – General Quality Awareness Training for new employees – 1.5-2 hours training for all new employees joining the organization and should be aware of the basic Quality Management System and the regulated environment of medical device. The training was delivered to hundreds of new employees in various companies, including GE Healthcare, Align Technology and Biosense Webster, with excellent feedback, and it provides a better starting point for new employees. Subjects included – what is quality, what is medical device and the main regulations in that industry, quality management system, quality policy, defect awareness, risk management, regulatory compliance, quality system monitoring, quality goals and objectives.
Auditing
Certified Lead auditor helping companies prepare for all regulatory bodies’ inspections & audits: FDA inspections and Notified Body Audits (ISO-13485, MDSAP, EU MDR, etc.) We work with quality teams, managers, and senior management to - • Prepare organizations to FDA inspections and Notified Body Audits • Perform mock audits, internal and supplier audits • Prepare a detailed audit plan • Train staff on all necessary aspects and ensure a successful outcome for the company. Due to the nature of the work majority of the engagements are confidential, below a review we have received from an FDA Inspector: “I have real high level of satisfaction, everything I would expect to see at minimum has been met and exceeded”
Executive Consulting
High-impact strategic yet pragmatic consulting to senior managers and quality-team mangers. Helping businesses understand & leverage the power of quality assurance and compliance, and their ability to impact both customers and patients' lives, while increasing organizational growth. Providing consultancy in the areas of - • Strategic quality planning & execution • Tailoring the Quality Management System to fit your organizational needs. • Helping you put customer and patients first in everything you do • Responding to audit observations • Providing QA management services.
