Digital Quality Management Software (QMS) for Medical Technology
Every aspect of the medical technology process must be controlled and monitored as per ISO 13845 and US FDA QSR requirements for medical device organizations. In order to ensure the integrity of the enterprise and to maintain quality assurance, the implementation of additional standards such as ISO 9000 must be pursued. This means installing efficiently designed processes throughout the operation from product development, to supply chain and shipping. By adopting a strong, process-centric culture, your company can smoothly transition from chaotic and ad hoc management systems to a smooth running operation that will increase profits.
About Medical Device Quality Management System (QMS)
A medical device quality management system involves the use of a structured make up of processes and procedures that encompass all aspects of design, storage, clinical data, supplier management, risk management, manufacturing, complaint handling, product labeling, distribution, and more.
Medical devices (most of them) will at some point require a form of QMS, though the complexity of the QMS will vary form device to device based in its classification. If for example a company makes a Class II (medium-risk) or Class III (high-risk) device, they will require a different QMS than those in the low-risk category making non reusable, nonsterile, non-measuring surgical instrument devices that would be labeled Class I.
Click the picture below to view a basic design breakdown of QMS as a general structure.
A Solution Designed for the needs of the Medical Technology Industry
Major life science companies partnered with Interfacing to deploy workflow solutions involving management and automation of point-to-point business processes. This includes laboratory, manufacturing, administrative, product and patient-related processes.
Interfacing’s process optimization & automation, SOP documentation digitalization and proactive regulatory vigilance solution, the Enterprise Process Center© Suite has brought about significant time savings with accelerated approval & validation, improved visibility and operational improvements for customers including the following:
End-to-end alignment – Single Source of Truth
The EPC allows life science organizations to easily align departments, regulations, procedures, controls, within a single repository to enable quick and standardized continuous improvements. Our technology allows information fragmenting to build reusable data fragments.
Accelerated approvals and validation
Interfacing QMS solution delivers sustained time saving by reduced training, updating and re-training time. The integrated approval, review and endorsement workflow also helps streamline the validation of new version of the standard operating procedures (SOPs) through fragmented content review and approval cycles to aid decision-making.
Digital Signature and Multi-Factor Authentication
EPC meets the very stringent requirements associated with compliance for FSA QSR, ISO 13845, GxP programs, and all SOPs and processes are parsed and documented, providing the audit trails meeting compliance with 21 CFR Part 11 Electronic Record and Electronic Signature (ERES) and a host of other regulatory requirements through RSA encryption, vault key story, and multi-factor authentication (MFA)
Improved Speed and Agility
Interfacing’s Enterprise Process Center© Suite is fully mobile and digital, providing life science organization with the flexibility of quality documentation readily visible through a variety of means including phone, tablets, graphical and textual to boost employee agility and self-training.
Multi-language support, auto-translation and localized content
Interfacing’s Enterprise Process Center© Suite provides insightful ways to manage global content, whether by automated translation suggestions for all fragments of content, or the ability to collect variance for SOPs by country, region or product-type
Life Science and Medical Device manufacturing companies trust Interfacing to provide a best-in-class solution to manage their quality content, data and workflows with scalability and security in mind. By implementing Interfacing’s Enterprise Process Center© Suite, Life Science and Medical Device manufacturing companies globally, have optimized their quality management system, boosted their regulatory digital data management, while leveraging user-specific quality content visualizations and intelligent downstream impact & assessment models.
Understanding compliance: ISO 13485, FDA QSR and GxP
We understand that the requirements placed on medical device companies in terms of compliance are very high and that ISO 13845, FDA QSR and GxP is an essential part of that program. By using our solutions, your company gains the accountability and consistency that will give you a cutting edge over your competition. Our tools ensure full visibility from end-to-end, all the way from the creation and amendment of a regulation to the approval and revision of the content through to the update and retraining of employees for standard operating procedures (SOPs). We see the full lifecycle management as moving parts of a complete ecosystem and that’s why are unique approach that combines regulatory requirements, documents, processes, work instructions, and governance.
ISO 13485
In short, ISO 13485 is an internationally recognized standard that the following countries have adopted: Europe, Canada, Australia and other markets. Excluding Canada, the application of ISO 13485 is not a requirement but is the de facto standard in use today as a measurement of full QMS compliance set forth on medical device regulations.
US FDA QSR
The US FDA QSR (also known as 21 CFR Part 820) was introduced prior to ISO 13485. All medical device companies in the US are required to meet this standard for national distribution but must comply with both regulations in order to distribute devices internationally. US FDA QSR must also be met by international companies wanting to do business with US customers.
Nuanced QMS
Other countries will have their own criteria to meet nuanced QMS requirements. For example while both Brazil and Japan have their own requirements, they are both based on existing US FDA QSR and ISO 13485 standards. On a positive note, these standards achieve harmonized quality management requirements to meet US, Canadian, European and all other QMS standards in effect.
GxP Compliance
Manage Content
Digital Signature
Ensure Transparency
Conduct Impact Analysis
Digital SOPs
Approval and Governance Workflow
Encourage Collaboration
ISO 27001 Cloud-solution
As part of our ongoing commitment to compliance and ensuring that our clients meet their regulatory requirements, we are always on the lookout for ways to help our clients attain and maintain full compliance. Interfacing is ISO 27001 certified and we are partnering with Amazon Web Services (AWS) for cloud-hosting since their commitment to compliance is proven, with global data centers compliance to SOC 1 Type II and ISO 27001. For more information on AWS compliance for ISO 18345, FDA QSR and GxP, please refer to their compliance program.
Discover how your organization benefits from an Interfacing QMS focused solution.
A key differentiator of Interfacing to other digital and business transformation consulting firms is that Interfacing offers its own innovative technology solution in support of transformation programs. Interfacing’s QMS supported solutions deliver the transparency required to reduce complexity, improve execution and facilitates agility and change.
Interfacing’s QMS integrated management system solution is a one-stop-shop for managing transformation programs. We know it’s a very competitive environment out there. It is for that reason our strength is in our commitment to maintain flexibility throughout the project lifecycle whether it is in our innovative products or in our team of experts.
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Document, improve, standardize, and monitor your business processes, risks and performance with Interfacing’s Business Process Management Software (BPM Software) the Enterprise Process Center®!