Enabling Business Success through Quality System Control and Regulatory Compliance for the Medical Device Industry
Here is a listing of contract services provided by Ron. While his work specializes in medical device applications, his skill set and capabilities cross over well to other industries.
DESIGN CONTROL
- Establish a robust design control process to assure that customer needs have been accurately translated into technical requirements (design inputs), verified and validated and converted to design outputs
- Provide guidance in the establishment of a design history file and device master record
- Facilitate the establishment of an effective change management process
- Ensure that proper controls have been established when working with contract manufacturing organizations
AUDITING (COMPLIANCE, PRODUCT, PROCESS, SYSTEMS, PRE-CERT.)
- Perform independent, internal audits for organizations who require independent auditors.
- Perform product, process and quality system audits to assure compliance with an organizations quality system, external standards and regulations
- Provide auditor training
- Provide simulated FDA QSIT inspections
- Specializing in FDA Quality System Regulations, ISO 13485 (Medical Devices), and ISO 14971 (Risk Management) audits
PRODUCT DEVELOPMENT
- Implement and establish a stage(phase)-gated product development processes
- Facilitate the identification of business critical work streams and deliverables to ensure that regulatory and business requirements are met
PROJECT MANAGEMENT
- Facilitate the creation, organization and implementation of project plans to ensure that appropriate records are created, maintained and available for regulatory filing
- Provide a system to ensure that project deliverables are synchronized to project tasks
QUALITY ENGINEERING
- Provide data analysis of critical-to-quality indicators, using statistical methods and techniques to identify, control and reduce unacceptable variation in manufacturing operations
- Facilitate the establishment of product specifications, so that both the customer and the supplier are assured of the outcome
- Establish statistical process control monitoring and process capability analysis
- Facilitate problem solving using statistical tools and methods
- Apply Cost of Quality principles to ensure that costs related to failures (internal and external) are identified, reduced and potentially eliminated
QUALITY MANAGEMENT SYSTEMS
- Provide and establish critical quality systems procedures, as needed, to facilitate timely and cost-effective product development and commercialization
- Assure that established quality systems comply with business appropriate regulations and standards
QUALITY SYSTEMS CERTIFICATION
- Contract auditor for DEKRA Business Assurance, for ISO 9001:2015 and ISO 13485:2016 quality management system certifications
- Perform quality system certification pre-assessment
- Facilitate quality system certification with notified body, including selection of registrar
RECORDS MANAGEMENT
- Set-up and maintain a records management system, as required, to meet business needs
- Provide document control administration
REGULATORY COMPLIANCE
- Assure that quality systems and project deliverables comply with business appropriate regulations and standards
- Facilitate the management of the control of documents of external origin
- Assure product design complies with regulatory submission requirements
RISK MANAGEMENT
- Assure that risk management requirements have been effectively established within an organizations quality system
- Oversee and manage risk management activities for a specific product under development, including facilitating the identification of potential hazard and failure modes, and managing risk mitigation and reduction activities
SUPPLIER SELECTION, QUALIFICATION AND QUALITY ASSURANCE
- Assist in the selection and qualification of critical suppliers
- Facilitate development of quality agreements with key suppliers
- Establish a supplier quality assurance and monitoring program
TRAINING
- Provide training in all aspects of quality management systems
- Provide ASQ certification training
