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.

 

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 Outsourced QA services to the following industries for resolution of compliance and regulatory challenges:

 

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

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-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

 

To begin the RCA^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.