IMPLEMENTATION-READY QUALITY SYSTEM FOR YOUR COMPANY
Smith Associates has developed implementation-ready Quality Management Systems aligned with FDA’s Quality Management System Regulation (QMSR), 21 CFR Part 820, and ISO 13485:2016. Each system includes Standard Operating Procedures, Work Instructions, supporting forms, logs, and a Quality Manual that can be tailored for start-up, small, or established companies marketing Class I, II, or III medical devices. Our quality system documents have been used during FDA inspections in the United States and internationally and are designed to help companies establish, implement, and maintain a stable, effective, and inspection-ready medical device Quality Management System.
Design and Development SOPs Under the QMSR
A formal Quality Management System should be established as the product moves from the concept and feasibility phase into controlled design and development. Under FDA’s Quality Management System Regulation and ISO 13485:2016, the company must plan and document its design activities and conduct formal design reviews at appropriate stages throughout the development process.
Your medical device or IVD should be developed under approved design and development procedures addressing design inputs, outputs, reviews, verification, validation, transfer, risk management, and design changes. The resulting documentation should support the testing and labeling information required for a 510(k) or other premarket submission and provide an organized design and development file and medical device file for future FDA inspections.
FDA expects applicable manufacturers to have an implemented and functioning Quality Management System before commercially distributing their devices. One of the most common problems we identify is that formal design reviews were either not conducted at appropriate development stages or were not adequately documented. Smith Associates can provide implementation-ready SOPs, Work Instructions, forms, and logs addressing design and development, document and record controls, complaint handling, and related QMSR requirements. Each company must review, customize, approve, train its personnel on, implement, and maintain the procedures according to its products and operations.
QMSR and ISO 13485 Gap Assessment and SOPs
ISO 13485:2016 is widely used by medical device manufacturers throughout the world, including U.S. companies that market their products internationally. Effective February 2, 2026, FDA’s Quality Management System Regulation (QMSR) incorporated ISO 13485:2016 by reference into 21 CFR Part 820, allowing manufacturers to maintain a more closely aligned quality management system for both U.S. and international regulatory requirements.
This alignment does not mean that ISO 13485 certification alone demonstrates FDA compliance. Manufacturers must also satisfy applicable FDA-specific requirements, including complaint reporting, Medical Device Reporting, corrections and removals, registration and listing, UDI, and device tracking.
During FDA inspections, investigators may evaluate design and development records, medical device files, production records, risk-management activities, supplier controls, nonconforming product, corrective and preventive actions, complaint handling, and MDR procedures. Under the QMSR, FDA may also review management-review, internal-audit, and supplier-audit records.
Smith Associates understands how ISO 13485:2016 and FDA-specific requirements work together and can provide gap assessments, Standard Operating Procedures, Work Instructions, logs, and forms to support an integrated Quality Management System. Each company must review and customize the documents, assign responsibilities, approve the procedures, train its personnel, and fully implement and maintain the system according to its products and operations.
MAKE SURE YOU ARE READY FOR YOUR NEXT FDA INSPECTION.
QMSR Quality Management Systems for Medical Device Companies of Every Size
Many medical device companies are small to medium-sized businesses with limited personnel available to serve as a full-time Quality Manager. However, company size does not eliminate the manufacturer’s responsibility to establish and maintain a Quality Management System that complies with FDA’s Quality Management System Regulation (QMSR), 21 CFR Part 820, which incorporates ISO 13485:2016 by reference.
Smith Associates was established in January 1994 to help start-up, small, and medium-sized medical device companies obtain FDA clearance and maintain regulatory compliance at a reasonable cost.
FDA’s issuance of a 510(k) substantial-equivalence determination allows a device to be commercially marketed, but it does not mean FDA has determined that the company complies with every other applicable requirement. Current FDA clearance letters remind manufacturers that they must also comply with requirements for registration and listing, labeling, Medical Device Reporting, the QMSR, and applicable electronic-product radiation-control provisions.
FDA also explains that the QMSR includes requirements addressing design and development, nonconforming product, corrective and preventive action, production controls, and documentation within the Medical Device File. Therefore, an applicable manufacturer must have an implemented and functioning Quality Management System before commercially distributing its medical device and must maintain that system throughout the product lifecycle.
Smith Associates offers comprehensive, implementation-ready Quality Management Systems designed for:
Start-up and small medical device manufacturers; and
Medium to large medical device manufacturers.
Each system includes applicable SOPs, Work Instructions, forms, logs, and Quality Manual documentation. Smith Associates can also provide customization, implementation assistance, personnel training, gap assessments, and inspection-readiness support.
The company is responsible for reviewing and customizing the documents, assigning responsibilities, approving the procedures, training its personnel, and fully implementing and maintaining the Quality Management System according to its products and operations.
QMSR Quality Management Systems for Specification Developers
If I do not physically manufacture the device, do I still need a Quality Management System? Yes.
If your company is the specification developer or finished device manufacturer, outsourcing production does not outsource your FDA responsibilities. Under FDA’s Quality Management System Regulation (QMSR) and ISO 13485:2016, you must maintain a Quality Management System appropriate to the activities your company performs.
Your responsibilities may include qualifying and monitoring contract manufacturers, establishing written quality agreements, controlling design and labeling changes, and ensuring the finished device continues to meet approved specifications and applicable FDA requirements.
During an FDA inspection, you must be able to provide controlled and readily accessible records, including applicable design and development documentation, the Medical Device File, approved specifications and drawings, supplier records, production and acceptance records, nonconformance and corrective action records, complaints, Medical Device Reporting evaluations, and correction or removal records.
These records may be maintained electronically or through controlled arrangements with your contract manufacturer, but your company must be able to obtain and present them promptly to FDA.
A properly implemented Quality Management System helps ensure that outsourced manufacturing remains controlled and that the device being produced and distributed is consistent with its cleared or otherwise authorized design, labeling, and specifications.
FDA Compliance SOPs for Medical Device Initial Importers
If I am an Initial Importer, do I need a Quality Management System?
An FDA initial importer generally does not need the same comprehensive Quality Management System as a medical device manufacturer. However, it must establish and maintain documented procedures and records for the FDA requirements that apply directly to initial importers.
These responsibilities may include establishment registration, complaint handling and forwarding complaints to the foreign manufacturer, Medical Device Reporting (MDR), reports of corrections and removals, recordkeeping, and medical device tracking when applicable.
A written quality agreement should clearly define the responsibilities of the initial importer and foreign manufacturer. However, FDA obligations that apply directly to the initial importer cannot be transferred or eliminated through a contract.
Smith Associates can provide implementation-ready SOPs, work instructions, logs, and forms tailored to your company’s applicable initial-importer responsibilities. Each procedure must be reviewed, approved, implemented, and maintained by your organization.
Implementation assistance and employee training are also available online or on-site.