Quality Management System (QMS) Services for Medical Devices Overview
Industry
Quality Management System (QMS) constitutes a set of designed and structured processes, policies, and procedures that help ensure that medical devices are safe and effective and compliant with international Regulatory standards.
The main purpose of QMS in the medical device industry is to ensure that the device meets the quality and safety standards established by the respective Regulatory bodies. The QMS for medical devices must comply with relevant regulations and standards such as the International Organization for Standardization (ISO) 13485:2016, United States Food and Drug Administration (US FDA) Quality System Regulation (QSR), and European Union Medical Device Regulation (EU MDR). These regulations and standards, each specific to a particular region, provide guidance and regulations for establishing, implementing, and maintaining the QMS within the respective areas. Medical device industries/organizations must establish and maintain the target country-specific standards for product distribution.
We provide you with assistance in the following medical device QMS requirements:
- ISO 13485:2016
- USFDA 21 CFR 820
- Medical Device Single Audit Program (MDSAP)
- Korea Good Manufacturing Practice (KGMP)
- Brazilian Good Manufacturing Practice (BGMP)
- Indian MDR 2017
- Quality System Documentation (QSD), Taiwan
- Ministry of Health, Labour and welfare (MHLW), Japan MO169
QMS is an essential element throughout the lifecycle of a medical device, starting from design and development right up to manufacturing, distribution, and Post-marketing Surveillance (PMS). It is a comprehensive system that involves various stakeholders, including manufacturers, regulators, healthcare providers, and patients.
QMS Services throughout Product Lifecycle
Phase 1: CONCEPT
- QMS planning/strategy.
- Identification of QMS requirements based on target markets.
Phase 2: PLANNING
- Establishment of QMS documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), templates, quality policies, manuals, etc.
Phase 3: DESIGN
- Creation of design control procedures and templates.
- Usability engineering/Human factors engineering.
- Risk management file.Establish templates/ WIs for regulatory submissions (dossier/ submission/ technical documentation)
Phase 4: VALIDATION
- Software as a Medical Device (SaMD) validation and implementation
- Audit readiness (internal/mock/ supplier auditing).
- Support with Regulatory submissions.
- Process validation – manufacturing, packaging, sterilization, and software.
- Product validation.
- Identification and traceability.
Phase 5: LAUNCH
- On-site and online training of stakeholders on QMS requirements.
- Post-approval Regulatory compliance.
- Labeling activities.
- Customer communication.
- Sales order process.
- Installation.
Phase 6: POST MARKET
- PMS plans, Post-Market Surveillance Reports (PMSR), and Periodic Safety Update Report (PSUR).
- Post-market Clinical Follow-up (PMCF) and Post-market Performance Follow-up (PMPF) plans and reports.
- Support with external body audits.
- Annual product quality review report.
- Post certification QMS maintenance and outsourcing.
- Design change management.
- QMS change management.
- Non-conformance management.
- Risk monitoring.
- Customer feedback.
- Preservation of products.
- Servicing
- Stability monitoring program.
- Customer property.
Regardless of the type of medical device, QMS plays an important role in ensuring product quality, reliability, and safety. Freyr provides QMS services across a range of products, as mentioned below:
- Medical devices
- In Vitro Diagnostic (IVDs) devices
- Combination products
- Software as Medical Devices (SaMDs)
Freyr’s Quality Management System Services
Quality Management System (QMS) Services for Medical Devices
- Cost-effective solutions.
- A qualified team of experts.
- An extensive partner network across the globe.
- Support with region-specific QMS services.
- Quality Assurance (QA).
- Staff Augmentation services.
- Extensive experience with diverse 510(k) registrations.
- Expertise with 510(k) compilation as per US FDA Premarket Notification (510(k)) requirements
- Additional support to handle 510(k) queries.
- On-time submission of deliverables
- Up to date with US FDA new amendments on SaMD
