Consulting Services Available

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