Quality Assurance Outsourcing
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Client
Distributor with quality assurance goals to launch a manufactured medical device
Industry
Medical Device
Business Challenge
Set-up and management oversight of QMS for emerging device maker with financial constraints
Project Timeline
6 months
QMS for Medical Devices
The FDA Quality System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Commonly referred to a Quality Management Systems (QMS), these required aspects include US FDA 21CRF820 Quality System Regulation, US FDA 21CFR806 Medical Device Correction and Removals, US FDA 21CFR803 Medical Device Reporting, 21CFR807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices , 21CFR801 Labeling, and ISO 13485: 2016 Medical devices — Quality management systems — Requirements for regulatory purposes Medical Devices.
Client Challenge
The savvy team had a business plan in place, a solid IP platform and a manufacturing plan, but they lacked a regulatory (RA) and quality pathway. Since they were bootstrapping the company, they implemented off-the-shelf QMS software, but later realized their approach fell short of a complete solution.
“We would absolutely recommend RCA to set up and manage a quality system. We couldn’t afford to hire personnel with RCA’s Quality Assurance outsourcing and our engagement allows us to tap into their experts as needed while we focus on growing the company.”
—Vice President Operations
RCA Approach
Regulatory Compliance Associates® Inc. was engaged to conduct a gap analysis and address shortcomings between their current systems against the RA and QMS requirements. RCA began a steady process of backfilling where they needed help, such as matching the purchased standard operating procedures with their business needs and remediating their product development process in accordance with the developing QMS.
As the launch date for the new product approached, RCA helped them implement CAPA and a complaint system, along with an internal audit plan.
- Management representative role
- QMS oversight
- Standard Operating Procedures
- Document Control and Quality Records
- Design History Record Review
- Design Change Process
- Post Production Monitoring
- Product Complaint Process
- Service & Repair Process
- Internal QMS audits
- Training of internal quality resources
- FDA inspection planning and training
- Quality System Registration to ISO 13485
- Quality engineering support including new electronics
To accomplish the resulting QMS system, RCA provided the company with experts in quality systems and quality engineering/electronics.
Results
With RCA’s outsourced QA expertise and their internal staff, the company was able to launch the product, comply with all regulations, pass regulatory audits, and implement their Quality Management System without hiring expensive executives. The company was able to salvage their investment in the QMS software. Additionally, because RCA set up a payment plan with fixed monthly fees, the company could meet their cash flow requirements.
After RCA’s initial engagement, the product experienced commercial success. As the company continued to grow and scale, RCA was retained for ongoing support as their outsourced QA/RA manager, working hand-in-hand to augment their capabilities, while keeping their expenses to a manageable level. As the company sales grew, it became attractive to investors and was acquired by one of the top 100 leading medical technology companies.
About RCA
Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of life science challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.