Quality Management System Services
Medical Device Development requires understanding of QMS.
The stakes are high in medical device development
The rigor and attention to detail necessary in every step of the medical device development process, as mandated by Federal Law, necessitates working with a partner who has a deep understanding of the requirements of quality systems for medical device development.
Kickr’s expert medical device team, which includes on-staff quality engineers, project managers, and biomedical engineers, will help you navigate the unique challenges of medical device development, documentation, prototyping and production utilizing our own Quality Management System. Kickr’s ability to blend deep engineering expertise with exceptional quality systems design enables levels of efficiency and performance unmatched in the industry.
What is a QMS (Quality Management System)?
An FDA-based quality management system (QMS) is a structured framework that a company follows to ensure its products are consistently produced and controlled according to quality standards. It involves detailed procedures and documentation for every step of product development, from design and manufacturing to testing and storage. This system includes protocols for risk management, corrective and preventive actions, and regular audits to ensure compliance with FDA regulations.
Kickr Design has QMS templates that we can customize for your product and company needs, which are compliant with 21 CFR 820 and ISO 13485:2016. Our QMS templates allow us to more quickly spool up a functional QMS for your company, are flexible where they can be flexible, and include coverage for:
- IEC 60601 Electrical Product Testing
- Templates for Class I Through Class III Devices
- ISO 10993 Biocompatibility
- Device & Packaging Sterilization
- Product and Vendor Verification and Validation
The development and implementation of an FDA-compliant QMS requires a highly trained quality team
The task list is extensive and complex from developing and releasing the SOPs and forms, performing risk assessments and DFMEAs, working through user needs, design inputs and outputs, and testing plans and verification. Online QMS systems are fantastic platforms, but they still require significant engineering and quality experts for successful execution. Most QMS management services are external to your engineering team, so your engineering staff or firm will need to be trained on the details of your particular QMS, leading to tens of thousands in additional training costs and potentially key information lost or incomplete.
Kickr Design has the capability to design and engineer your project with the Quality and QMS resources to prepare, implement and manage your Medical Device‘s QMS all in one place. This means lower training costs, quicker implementation and seamless interaction between Quality and Engineering, saving you time and reducing potential pitfalls in your path to FDA certification! Kickr Design’s fully managed QMS services provide quality engineering resources that are blended seamlessly with our expert biomedical engineering capability.
Let us become your quality team!
Covering the most important aspects of a QMS
Why do you need a QMS for your medical device?
Ensures that medical devices are designed to meet user needs and regulatory requirements, reducing the risk of defects.
Maintains organized and accurate records of procedures, changes, and approvals, ensuring traceability and compliance.
Identifies and addresses potential and existing issues, preventing recurrence and improving overall product quality.
Assesses and mitigates potential risks throughout the product lifecycle, safeguarding patient safety and product reliability.
Regularly evaluates the effectiveness of the QMS, ensuring continuous improvement and adherence to FDA regulations.
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