Product quality for medical device manufacturing is a non-negotiable requirement. At the core of US regulations is the FDA’s Quality System Regulation (QSR), a framework designed to ensure that every medical device on the market is safe, effective, and made to the highest standards.
If you’re a medical device company (OEM) looking for a reliable contract manufacturer, understanding QSR compliance and how your partners handle it could be the key to smooth product approvals and avoiding costly delays. Let’s break it down.
The FDA’s QSR, detailed in 21 CFR Part 820, lays out the Current Good Manufacturing Practices (CGMP) for the entire lifecycle of finished medical devices—from design and manufacturing to packaging, labeling, and servicing. The regulation's goal is to ensure every device is made consistently to meet all requirements and specifications.
QSR applies to both domestic and foreign manufacturers whose devices are intended for distribution in the United States. Even if you outsource part or all of the manufacturing, the OEM is still fully responsible for ensuring all vendors are compliant.
Key elements of QSR include:
Design Controls: A structured process for turning user needs into product specifications, including risk management and design validation.
Document Control: Written procedures and controlled documents for all manufacturing and quality assurance activities.
Production and Process Controls: Validation of critical processes and proper equipment calibration and maintenance.
Corrective and Preventive Actions (CAPA): A system to identify, investigate, and fix quality issues while preventing them from happening again.
Purchasing Controls: Evaluating and approving suppliers and verifying that purchased components meet requirements.
Identification and Traceability: Clear identification and tracking of devices throughout production.
Complaint Handling and Servicing: A documented system for responding to customer complaints and servicing products in the field.
Training: Ensuring employees are trained and qualified for their assigned duties.
Internal Audits and Management Review: Regular evaluations to ensure the Quality Management System (QMS) is effective and compliant.
The goal of QSR isn’t just to check a box. It’s about creating a system that protects patients and manufacturers by consistently producing high-quality products.
If you’re an OEM outsourcing manufacturing, your contract manufacturer’s QSR compliance directly impacts your business.
Here’s why:
FDA Inspections: The FDA can inspect your supplier, and any noncompliance could delay your launch or trigger a product hold.
Product Recalls: QSR violations could lead to recalls or other field actions, disrupting your supply chain and damaging your brand reputation.
Regulatory Submissions: Submitting a 510(k) or PMA requires proof of QSR-compliant manufacturing.
Customer Trust: Consistent product quality and regulatory conformity are essential for earning and keeping the trust of your customers and gaining market access.
You can't afford to partner with manufacturers who cut corners. Your business and your patients depend on a reliable partner.
At Sanbor Medical, compliance isn’t just a requirement. It’s built into how we operate. As a fully FDA-registered medical device contract manufacturer, our facilities are regularly audited by both the FDA and our OEM partners.
When you work with us, you can expect:
FDA-inspected facilities in both the US and Southeast Asia.
A fully implemented and continuously improving QMS that meets both FDA QSR and ISO 13485 standards.
Documented procedures for design control, process validation, and quality assurance.
Extensive experience in contract manufacturing of medical devices.
A dedicated quality team overseeing production, inspection, training, and CAPA.
Secure recordkeeping and document traceability across all production stages.
A competitive labor cost structure that never compromises on compliance or quality.
Sanbor Medical doesn't just follow QSR; we build it into every quote, every drawing review, and every production run.
The FDA’s Quality System Regulation is more than a rulebook—it's the foundation of trust in the medical device industry. Choosing a contract manufacturer that fully understands and complies with QSR can help you avoid regulatory headaches, reduce risk, and protect your reputation.
Sanbor Medical is proud to support medical device companies who demand both regulatory excellence and cost efficiency. Our FDA-compliant systems, global footprint, and experienced team make us a partner you can count on—from concept to commercial scale.
Ready to get started? Contact our team today
