USA Regulatory ServicesWe provide a full range of QMSR compliance services designed to assist medical device companies in understanding and adhering to the new regulatory standards, having assisted numerous businesses with QSR and ISO 13485:2016 compliance. Our services are tailored to the unique difficulties presented by the QMSR, utilizing our knowledge to enable a seamless transition. We assist you in more effectively allocating your resources so that your shift to QMSR compliance is finished on schedule, within budget, and without interfering with regular business operations. Every QMSR support engagement is customized to meet your specific needs and may involve, but is not restricted to:
Development of Quality management system
We guide and assist you in developing a Quality management system in accordance to 21 CFR 820 – QMSR.
Requirements
§ 820.10 — Requirements for a Quality Management System
(a) Documented quality management system
- Requirements of ISO 13485
(b) Applicable regulatory requirements
(1) ISO 13485 Clause 7.5.8 — Identification; Unique Device Identification (UDI), under 21 CFR Part 830
(2) ISO 13485 Clause 7.5.9.1 — Traceability: General; 21 CFR Part 821, where applicable
(3) ISO 13485 Clause 8.2.3 — Reporting to regulatory authorities; 21 CFR Part 803
(4) ISO 13485 Clauses 7.2.3, 8.2.3 and 8.3.3 — Advisory notices; 21 CFR Part 806
(c) Design and development
Manufacturers of class II, class III, and some of class I devices must comply with the requirements in Design and Development, Clause 7.3 and its Subclauses in ISO 13485. The class I devices are as follows
| Sr. No. | Section | Device |
|---|---|---|
| 1 | 868.6810 | Catheter, Tracheobronchial Suction |
| 2 | 878.4460 | Glove, Non-powdered Surgeon's |
| 3 | 880.6760 | Restraint, Protective |
| 4 | 892.5650 | System, Applicator, Radionuclide, Manual |
| 5 | 892.5740 | Source, Radionuclide Teletherapy |
(1) Devices automated with computer software -
(2) Specified Class I devices listed in Table 1
(d) Devices that support or sustain life - must comply with the requirements in Traceability for Implantable Devices, Clause 7.5.9.2 in ISO 13485
(e) Enforcement - under section 501(h)
Subpart B — Supplemental Provisions
§ 820.35 — Control of Records must comply with the requirements of Clause 4.2.5 in ISO 13485
(a) Records of complaints
(1) Device name
(2) Date complaint was received
(3) UDI, UPC and other device identification
(4) Complainant's name, address and telephone number
(5) Nature and details of the complaint
(6) Correction or corrective action taken
(7) Reply to the complainant
(b) Records of servicing activities
(1) Device name
(2) UDI, UPC and other device identification
(3) Date of service
(4) Individual(s) who serviced the device
- (5) Service performed
- (6) Test and inspection data
(c) Unique Device Identification - In addition to the requirements of Clauses 7.5.1, 7.5.8, and 7.5.9 in ISO 13485
(d) Confidentiality
§ 820.45 — Device Labelling and Packaging Controls
(a) Examination of labelling and packaging for accuracy
- (1) Correct UDI, UPC or other device identification
- (2) Expiration date
- (3) Storage instructions
- (4) Handling instructions
- (5) Additional processing instructions
(b) Documented release of labelling for use with Clause 4.2.5 of ISO 13485.
(c) Prevention of labelling and packaging mix-ups and documentation of inspection results - accordance with Clause 4.2.5 of ISO 13485.
Analysis of Regulatory Gaps
We thoroughly examine your existing quality management system in comparison to the QMSR in order to find weaknesses and potential areas for development.
Tailored Compliance Approach
We create a customized plan to close any gaps found based on the gap analysis, guaranteeing that your systems meet all QMSR regulations.
Integration of Risk Management
In order to ensure compliance with the QMSR's emphasis on risk-based decision-making, we assist you in integrating risk management procedures across your quality management system.
Updates to Documentation
In order to comply with the strict documentation requirements of the QMSR and ISO 13485:2016, we help you review and update your SOPs, quality manuals, and records.
Training and Development for Employees
To make sure your team is knowledgeable of the QMSR modifications and their roles and duties within the revised system, we offer specialized training sessions. Getting Ready for FDA Inspections
We use readiness assessments and simulation audits to get your team ready for inspections because the FDA's inspection methodology is expected to change under the QMSR.
