Medical Device QMS Implementation, Simplification & Compliance
Do you need to set up a complete quality management system for your emerging medical device/IVD company? Do you feel like your existing QMS is overly burdensome and complicated for your business? A simpler system may help reduce costs and compliance issues.
If you need help implementing, simplifying, or maintaining a quality system for your medical device or in vitro device, look no further than Cannon Quality Group. Our quality team has a passion for keeping things simple and risk-based, and we have years of experience helping MedTech startup companies reach their business goals no matter what stage of the product life cycle they’re in.
To learn more about our QMS implementation and maintenance services, contact us online today.
Our Medical Device Quality Management System Solutions
Since 2010, we’ve offered our services to MedTech startup companies who needed simple, risk-based systems to meet regulatory requirements for design control, internal audits, supplier controls, validations, and more. We help find the right-sized QMS to enable you to get more done, simpler, and faster! We’re sensitive to the fact that every company has different needs depending on their stage of development and business goals. 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. This is 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.
- Ongoing QMS maintenance – We can maintain your quality system in many areas, including your ASL for supplier controls and certification, monitoring CAPAs, NCMRs, and preparing documentation and statistics for your regular management reviews.
- And more
View our full list of services here. If you or your medical device/in vitro device company needs assistance developing and implanting any portion of a quality management systems listed above, contact Cannon Quality Group today.
Medical Device Quality System Compliance
Our company’s mission is simple: getting safe medical devices and in vitro 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 Law (California FDB)
- Medical Device Directive
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62366
- And more
If your medical device is in need of a QMS you can rely on, contact Cannon Quality Group. We can also perform QMS maintenance to ensure that your system is up to date and meets all necessary regulations.
Choose Cannon Quality Group for Medical Device QMS Solutions
When you need professional assistance developing, tweaking, or maintaining your quality management systems, call Cannon Quality Group. We have the passion, resources, and experience to provide audits, gap assessments, and whatever else you need to reach your business goals.
Contact Cannon Quality Group today!
What Our Customers Have to Say
“For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system have allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance.”
– Andrew Hosford, Director of Engineering – Gauss Surgical