Quality Management Services for
Simbex brings decades of experience in managing compliance for MedTech Companies
Medical Device Quality Management Consulting Services
At Simbex, we have over 23 years of experience in medical device quality assurance. Our experts provide tailored systems for design, development, production, and delivery of your medical device.
We assist with quality system implementation and management to achieve quality system compliance and de-risk innovation for our partners’ complex medical and consumer health products. Our tailored Quality as a Service solution ensures your medical or consumer health device meets quality requirements globally.
No matter what stage of the medical device journey you’re in, quality is the beating heart of your operations. There’s no “start” and “end” point to quality. Rather, it’s an ongoing activity that, when done correctly, will keep your company focused and agile.
Why Quality Management is Important for Medical Devices
Medical devices are designed to improve the lives of patients and enhance their quality of life, and it is crucial that these devices are reliable, safe, and effective.
A well-designed and properly implemented quality system can help speed development and get the product to the end user faster by streamlining processes and reducing risk of errors and delays. By having clear product requirements, documentation, and procedures in place, development activities can be carried out efficiently and effectively.
Having a well-established quality assurance program not only ensures that your medical device meets the necessary regulatory requirements, but also protects patients by providing them with safe and effective products. It helps verify that each step in the process is thoroughly developed, documented, and reviewed, reducing the chances of human error or oversights. Additionally, a strong quality assurance system minimizes liability risks for the manufacturer and improves overall confidence in the product.
Traceability is King in Medical Device Development.
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Streamlining Quality Assurance Activities with Simbex’s Expertise
Quality assurance activities include, but are not limited to, developing and maintaining standard operating procedures, managing CAPAs and complaints, and executing internal audits. These activities can feel overwhelming and daunting, especially when you’re feeling motivated and excited to bring a brand-new product to the market. These processes can involve a significant amount of record-keeping and review, which can be time-consuming and challenging to manage without prior experience. This is where the assistance of a specialized team can make all the difference.
Rather than taking on these activities alone, you can rely on Simbex’s 23 years of quality experience to lead the effort. Our team knows what works and what doesn’t, which will help get your product into your users’ hands faster and keep your product and company compliant.
Essential Systems and Processes Managed by Quality Experts
Systems and Processes Managed by Quality Systems and Quality Experts Often Include:
- Quality Manuals
- Design & Development Documentation (User Needs, Design Inputs, Specifications, Verification, Validation)
- Process Instructions
- Operating Procedures
- Complaint Handling
- Risk Management Systems
- Manufacturing Records (Purchase Orders, Travelers/Routers, Inspection)
- Training Documentation
- Internal Audits
- Medical Device Reporting
- Supplier Management
- Recalls & Corrections
- Corrective & Preventive Action
- Document Management/Version Controls
Partnering with Simbex for Customized Quality Assurance Solutions
At Simbex, our quality assurance experts are committed to addressing your unique needs and resolving your pain points by delivering customized solutions that empower your team to achieve success.
This collaboration can start with pre-market activities as you plan for market clearance. Simbex QA experts can guide you through the design phases and develop your QMS alongside your product. We’ll help you stay lean and pass external audits, with the goal being no or minimal findings.
Often, we work with our clients to establish and maintain their quality system for the long term, providing QMS procedures and forms, infrastructure, and necessary staff training.
Our QA services establish & maintain your quality management system so you can focus on what you do best – develop innovative technologies to improve lives.
Maintaining Quality Assurance for Your Product Post-Market with Simbex
Once your product hits the market, quality assurance becomes even more critical. Our commitment to Quality ensures that your business stays compliant while your product is in use. This model is perfect for start-ups dedicated to providing high quality throughout the product lifecycle.
Through long-term collaboration, Simbex QA personnel can act as final quality sign off for quality records, manage complaints and required reporting, oversee company regulatory registrations, conduct post-market surveillance analysis activities, and coordinate with contract manufacturers and internal design and engineering teams.
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Simbex specializes in ISO 13485, 21 CFR 820, and EU MDR compliant quality systems for Medical Devices