PERFEQTA’s Quality Management System for Medical Devices
Medical Device Regulations have compliance standards such as IEC 62304 that specify the life cycle requirements of medical software and any software which is contained within medical devices. Standards such as IEC 62304 are used for medical device manufacturers who must comply with medical device regulations in the US and beyond. As a result of heavy regulation, healthcare organizations and medical device manufacturers require systems which can manage both the hardware and software compliance of medical devices. This ensures that both the hardware and software teams meet all regulations for QMS, QC and QA compliance.
Regulators want to ensure that all of a medical product’s requirements are managed properly. Quality management processes are areas of monitoring for hardware or software features in medical devices. A QMS for medical device compliance program is a structured system for documenting the procedures and processes implemented throughout a part, or the lifecycle of a medical device. It can cover a variety of aspects such as medical device design, manufacturing, supplier management, product labeling, storage & distribution, clinical data, risk management, and complaint handling. QMS standards are enforced in most of the world’s markets through ISO 13485; Quality Management System for Medical Devices, and the US FDA QSR: Quality System Regulation for Medical Devices.
1000+ PERFEQTA solutions support key medical device software standards and regulations, including:
ISO standards for quality and risk management for medical devices (e.g., ISO 13485, ISO 14971)
IEC standards for medical device lifecycle requirements (e.g., IEC 62304)
- FDA regulations applicable to medical device development (e.g., 21 CFR 820.30 and CFR Part 11)
- EU medical device directives and regulations
- • Agile practices in medical device software development, AAMI TIR45
Medical Device Quality Management and Beyond
Healthcare compliance software highlights many requirements which must be met, and sub-requirements that are created for quality control. Hardware and software teams developing medical devices require quality management as part of their organizations process. This ensures that there is no room for confusion for quality control and everyone is working the same compliance program requirements. Process improvement is easily achieved with PERFEQTA’s quality management system for any healthcare organization or device manufacturers.
PERFEQTA software for medical devices is a SaaS for your organization which includes Document Management, Quality Control, Inspection Management, Electronic Signature, CAPA Management, Audit Management, Training Management, Complaints Management, Supplier Quality Management, Calibration Management, Incident Management, Field Safety Action Management, Permit Management, Material Compliance Management, Change Management, Nonconformance Management, Forms Management, Maintenance Management, Validations, Dashboards, Reports, Security, and Analytics. PERFEQTA is so much more than a quality management system! Manage all your organizations work into one platform. Replace your paper forms and hard-to-manage software with one solution across multiple departments without compromise and stay in full compliance while eliminating risk.
PERFEQTA is compliant with HIPAA, FDA 21CFR Part 11 and Part 820, ISO, CLIA, GAMP5 and GxP.
Real-time QC Monitoring
Receive instant updates of quality control events across equipment, personnel and procedures.
CAPA and SCAR Integration
Automate CAPA and SCAR processes to save exponential amounts of time.
Integrate with over 1500 software tools and systems, including BECS, ERP, MRP, LIS, and CRM.
Offline Data Capture
Add data to PERFEQTA modules without an internet connection to work from anywhere.
Keep your highest priority workflow items at the top of your personalized dashboard.
Instantly know if quality assurance procedures are not followed or have been modified.
Delete every paper form you use daily and replace it with automated software apps.
Network Security Integration
Easily integrate with your existing enterprise network security solution.
Why implement PERFEQTA for your company?
- Easily transform your medical device manufacturer quality management with our vetted system software experts
- Work with healthcare compliance software Software-as-a-Service experts since 2005
- Ensure your medical device quality control goals are met and your flow issues are resolved
- Choose from flexible deployment options and custom timing for testing, quality control and risk management
- Solve all of your organization’s friction points with one customizable solution to ensure compliance
- Use pre-built solutions or easily build your own according to your company budget
- Receive unwavering support from software experts if you have questions about your compliance workflow and quality procedures
Industries we strive to impact
“After using the PERFEQTA platform, MD Anderson users reported that PERFEQTA made a great impact on their daily operations. They praised PERFEQTA’s intuitive design, flexibility, ease of use and the support from the PERFEQTA team. The platform scored exceptional marks in regard to reliability and the implementation process.”
“The most immense value you get out of PERFEQTA is all of the time you save, and now you can do all sorts of additional tasks you weren’t able to do before. Our processes before PERFEQTA were very slow, on paper, with a lot of record retention required. Now that all of that has gone away, we are so much more efficient, including our lot release process.”
“PERFEQTA is the perfect solution for a regional blood center because it grows with you. We can automate our daily quality control processes, improve efficiency and reduce costs. Hoxworth expects to save 4x our investment in spending in our first year on the platform. Transitioning our team from paper to PERFEQTA has been transformative.”
PERFEQTA’s pricing is simple, always ROI-positive, and easy to budget. We will build a customized pricing plan that fits the needs of your organization and you won’t pay for features you won’t use. When you contact us, we’ll reach out on a discovery call to gather the necessary information about your organization’s goals and provide you with a pricing statement on the first call.
The PERFEQTA promise
We’re confident PERFEQTA’s healthcare compliance software for quality control, and compliance will manage effectiveness while maintaining security for your organization. PERFEQTA is faster to implement than buying off-the-shelf quality control software or building your own compliance solution. We promise our efficiency in implementing on your organizations environment in days not weeks.
With 99% customer satisfaction, PERFEQTA has grown with the QMS needs of our clients in life science and beyond since 2005. As your needs grow, PERFEQTA grows with you. Schedule a demo for your organization today!