Medical Device Quality System Compliance
Our company's mission is simple: getting safe medical devices to patients with simple, risk-based quality systems. We are excited to have had the opportunity to work with so many companies and bring new technology to the marketplace. We've helped many of these companies achieve their business goals while maintaining the level of quality compliance needed to earn certifications and pass industry standards, and we can help you as well. We have experience with medical device quality systems to achieve compliance for the following regulations, standards or organizations:
- Sherman Act / CAL FDB
- Medical Device Directive
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62366
- And more
Zi-Medical staff are experts in Quality Systems
Medical Device QMS Implementation, Simplification & Compliance
Do you need to set up a complete quality management system for your medical device?
Our quality team has a passion for keeping things simple, risk-based, and has years of experience helping medical device startup companies reach their business goals no matter what stage of the product life cycle they're in. A simpler system will help reduce costs and compliance issues.
- To learn more about our QMS implementation and maintenance services, contact us online today.
Our Medical Device Quality Management System Solutions
With decades of combined experience, we've offered our services to medical device startup companies who needed simple, risk-based systems to meet regulatory requirements for design control, internal audits, supplier controls, validations, and more. We help you get more done, simpler, and faster! Some of our services include:
- Document control - Our team can help you develop effective procedures for document creation, filing, review, and more.
- Design control - Prove that your medical device is safe and meets the needs of your target consumers with effective design control practices. The best opportunity to confirm your device can be produced consistently to your high standards, before having to experience major production issues.
- Audits - We offer both internal and supplier audits to help you improve your quality system to meet regulatory requirements and make you aware of your supplier's quality system capabilities.
- Risk management - In accordance with ISO 14971 and ISO 9001:2015, risk planning when developing a QMS has shifted to being more proactive. This means planning and designing an effective risk tolerant quality system has never been more important.
- Production control - The last opportunity to ensure your device is safe and effective. We recognize that the right process checks will save a lot of hidden costs.
- Complaint management - Cannon Quality Group can help your company develop a valuable complaint management system that will help log, evaluate, and act on customer complaints quickly and purposefully, including assessing medical device reporting requirements.
Contact us for our full list of services. If you or your medical device company needs assistance developing and implanting any portion of a quality management systems listed above, contact Zi-Medical today.
When you need professional assistance developing or tweaking your quality management systems, call Zi-Medical. We have the passion, resources and experience to provide audits, gap assessments, and whatever else you need to reach your business goals.
Contact Zi-Medical today!