Regulatory Compliance for Medical Device Manufacturer

QSN assisted medical device manufacturer with the successful completion of a regulatory compliance initiative which positioned them to be recognized as a premier provider of bone marrow aspiration, biopsy, and harvest needles.

Company profile

• Established in the late 80’s.
• Reputation for delivering high quality products to hospitals and physicians in the clinical setting.
• Therapeutic areas include: Oncology and hematology.
• New to the industry and had recently established registration with the FDA as a medical device manufacturer (FDA 21 CFR Part 807).

Business situation

The medical device manufacturer wanted to be recognized as a premier provider of bone marrow aspiration, biopsy, and harvest needles.

Technical situation

The medical device manufacturer contracted out the manufacturing of the needles and was responsible for marketing and distribution, which was their technical expertise. They did not yet have the regulatory expertise in house, however, and needed the compliance support to establish an appropriate quality system (FDA 21 CFR part 820).

Solution

QSN was engaged to assist the medical device manufacturer in the implementation of the appropriate quality system regulations (QSR) for compliance with FDA requirements. QSN initially assessed the scope of work by conducting a gap analysis. This type of review allowed them to obtain a clear map of the process and it’s supporting activities, roles and responsibilities, and compliance gaps and risks. A project plan was developed to manage all compliance activities and associated timelines for implementation. QSN determined that because the manufacturing was being completed externally, supplier controls were a critical component of the quality system, specifically supplier qualification and certification. Additional areas of focus included management responsibility, quality audits, document controls, purchasing controls, identification and traceability, acceptance activities, nonconforming product, corrective and preventative action, handling, storage, distribution, and records. Working with the employees, documented processes were put in place for each critical element.

Benefits

QSN was responsible for establishing a complete quality system that not only defined roles and responsibilities, but included a framework of procedures, work instructions and forms required to document all quality system efforts. Most importantly, the framework provided an efficient and effective business operation that worked well for the organization moving forward. Without notice, the FDA visited the medical device manufacturer who underwent a rigorous audit of the facility, which resulted in no critical or major findings – demonstrating that the implementation was a success.