Quality Assurance and Control
Medical device quality management systems are all about providing the rigor and discipline to drive product quality that meets customers' needs and delivers the information which is the lifeblood of management effectiveness.
In the medical device industry, the ISO 13485 standard is an effective solution for the comprehensive requirements of a quality management system. Adopting ISO 13485 furnishes a strong foundation for manufacturers to stay compliant with regulations and demonstrates a commitment to the safety and effectiveness of medical devices.
ISO 13485 is the best globally accepted model a medical device organization can implement to demonstrate compliance for regulations and laws of the medical device industry. ISO 13485 is required, and beneficial, in supporting regulations around the world, including the U.S. FDA, EU MDR, EU IVDR, MDSAP, TGA, Health Canada, and other high regulatory organizations.
1. Design Quality Services
2. Quality Management System (QMS)
3. Supplier Quality Services
1. Design Quality Services
Our design quality engineers work with new product development teams to ensure the latest quality management system is enforced in the development process.
- Identification of critical characteristics in the design
- Train and provide clarification on QMS to the engineering and manufacturing team
- Responsibility in completing a risk assessment and FMEA
- Development of Measurement System Analysis (MSA) for the best inspection methodology
- Traceability Matrix
- Risk Management File (RMF)
- Design Input/Output and Design Transfer
2. Quality Management System (QMS)
A well-executed quality system drives excellence, bringing your business processes under control, and giving you the information, you need to drive continuous improvement.
- Adapt or build a new quality management system
- DHF, RMF, Technical File Remediation
- Implementation or upgrade of systems to comply with ISO 13485:2016, FDA 21 CFR 820, and EU MDR
- Outline how to review and improve processes across your organization
- Compliance to ISO 14971, ISO 62304, IEC 60601 4th Edition
- Assist and participate in U.S. FDA/NB inspection/audit
3. Supplier Quality Services
Our supplier quality engineers work with the manufacturing facilities and suppliers to ensure that the best quality product is received.
- Responsible for Supplier Corrective Action Reports (SCAR)
- Improve supplier-related metrics including on-time delivery and better FPY
- Execute processes like 8D and root cause analysis
- Ensure proper documentation including pFMEA, risk analysis, and process capability
- Perform periodic supplier audits
- Notified Body(NB) Audits
- Coordinate between R&D and Supplier
- Supplier Validation Processes
What expertise we provide under this service
Regulatory Consulting and Services
We can help you comply with local, regional, and global regulatory requirements affecting your products.
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Clinical Evaluation Report (CER)
Objective of the CER is to determine whether there is sufficient clinical evidence to confirm the safety and performance of the medical device.
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Post Market Clinical Follow-up (PMCF)
PMCF is an active collection of data on the clinical experience of your device aftermarket release.
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Performance Evaluation Report (PER)
A continuous procedure to assess data and analyze to demonstrate the validity, analytical and clinical performance of that device.
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Post Market Surveillance
A team of medical device industry professionals offer expertise PMS to comply with global and country specific standards.
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