Robust Quality Management Systems
Manufacturing relationships, Distributing quality
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.
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
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
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
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
