Medical device companies require successful implementation of quality engineering and validation to ensure products consistently meet customer and patient needs. NSF’s strategic, tactical and technical expertise will help you with program management, quality assurance and regulatory compliance. Our medical devices consulting services assist with product design and development processes, risk management, manufacturing process development, validation and control. Our approach spans the product lifecycle and supports commercialization and sustainability, as well as addresses product issues and remedial actions to ensure continued safety and effectiveness.
For more information about NSF medical device quality systems implementation, remediation and auditing, please email firstname.lastname@example.org or call +86 21 52377700.
Our comprehensive operations and risk-based services approach focus activities and resources on the deliverables that matter most to your specific requirements. We deliver results by applying efficient and effective best practices in:
Planning and Project Management
- Prioritize risk factors, business needs and opportunities
- Develop multi-function integrated plans
- Outline project/program objectives, requirements and constraints
- Establish operating mechanisms to drive deliverables, mitigate project risk and define value
- Deliver consistent communication appropriate to various levels of the organization
Design Control and Product Change Management
- Create design, development and change management plans
- Perform design verification and validation
- Assist and/or lead the software development lifecycle
- Ensure a robust engineering change management process
- Address risk management (EN ISO 14971:2012) through planning, analyses, evaluations and controls
- Develop or remediate risk management files
- Ensure postmarket risk re-evaluation
- Develop device history records (DHRs) and device master records (DMRs)
- Document and implement change control
- Provide process and test method characterization
- Develop and implement validation programs including validation master plans, process validation, test method validation, and software and automated systems validation
- Provide prequalification, qualification and validation of supplier programs
- Develop supplier evaluations/scorecards
Production and Process Controls
- Ensure production controls consistently deliver products that meet design specifications
- Develop and implement processes, and help address complaint and failure investigations, nonconformities and CAPA
- Establish and deliver on key performance indicators and quality metrics
Our staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practices to help our clients achieve sustainable and compliant quality systems.
Tom Dzierozynski - Executive Vice President, Pharmaceutical Services
Phone: +1 847.984.3802
Tom Dzierozynski has over 20 years’ experience in the pharmaceutical, medical device and biologics industries. Through comprehensive and practical knowledge of operations, regulatory affairs and quality systems, he has developed and implemented risk-based strategies that integrate varying business functions to drive ownership and improve operational and quality performance. He’s led technically-oriented projects focusing on design controls, verification and validation, process improvement, regulatory market clearance, risk management and implementation of corrective actions to address/avert enforcement actions. Earlier in his career, Mr. Dzierozynski was Vice President of Validation Services for Quintiles Consulting, and held quality, engineering and management positions at Baxter Healthcare Corporation.
Challenge: A Fortune 500 medical device manufacturer needed support following an FDA warning letter.
Solution: NSF provided strategic support and hands-on consultation for a remediation effort covering the seven subsystems of the QSR. As part of this multi-phased approach, NSF led training and coaching sessions for company subject matter experts, developed the remediation program including the creation of a program charter, and built and managed the Program Management Office.
Challenge: A Fortune 500 Class II medical device manufacturer wanted to remove a consent decree.
Solution: NSF conducted a series of baseline and verification audits, and provided ongoing support following these audits at the facilities and for the products identified in the consent decree. We also served as the third-party certifier for three separate quality systems certifications as identified in the consent decree.
Challenge: A global medical device manufacturer was facing withdrawal of CE certification for its Class IIb and III products.
Solution: NSF mobilized a team of senior EU regulatory specialists to work in various locations in both the U.S. and UK. NSF acted as intermediaries between several EU competent authorities and the notified body to establish an appropriate action plan to address fundamental regulatory, product validation and quality system deficiencies. NSF coordinated and managed the implementation of regulatory and clinical processes to remediate multiple technical files leading to the successful reissue of CE certification.
Why Work With NSF?
At NSF, we are committed to protecting patient health and safety. We consistently deliver results through the development and implementation of a comprehensive plan and oversight approach to ensure products are designed and manufactured with quality standards to meet customer and patient needs.