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Comply, Create, Accelerate
Reduce time to market for your medical device with lean, intelligent workflows
Key Benefits
User-Friendly and Quickly Deployed
Lean, intelligent workflows, incorporating FDA, ISO and GxP best practices
Electronic Records and Signatures complying with FDA 21 CFR Part 11
One source of truth for approved documents
Enable remote team member collaboration
Rapid document retrieval
Risk reduction for investors & acquirers
Facilitating ISO 27001 compliant security
Reduce time to market for your medical device
Easy to integrate with your existing
QMS
Protect master document integrity
Facilitate control and approval of document changes
What CompanionQMS can do for you
Host your entire QMS
One source of truth. Host the necessary legal evidence in one secure location
Integrated medical device QMS experience
Lean and efficient workflows enabling users to apply QMS requirements routinely and seamlessly
Accelerate your journey to device approvals
CompanionQMS rapidly deploys your QMS and facilitates immediate Design History File preparation
Provide a legally compliant electronic signature and electronic record solution
Meet the legal requirements for record approval and retention. CompanionQMS facilitates electronic signature approval and master record retention in accordance with FDA 21 CFR Part 11 requirements.
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CompanionQMS Solutions Include
Complete QMS Content Management with optional approval workflows including for example:
Change Request
CAPA, Corrective & Preventive Action
Non-Conformance
Complaints
Supplier Request
Approval Request
Some of our innovative customers
Perfuze
Innovative Medical Technology to treat Acute Ischemic Stroke
Rockfield Medical
Innovative Feed Delivery Systems
Aurigen Medical
An Electrophysiology and Structural Heart Company
Bluedrop Medical
An Electrophysiology and Structural Heart Company
Loci Orthopaedics
Innovative Orthopaedic Solutions
Customer Testimonials
Perfuze reaching Clinical Trial, CE mark and US FDA Breakthrough
Designation milestones accompanied by CompanionQMS
The Opportunity:
Perfuze is developing and manufacturing groundbreaking technologies for clot removal in stroke patients. Devices are intended for global markets including the US and Europe. The unmet critical clinical need requires a rapid response with an efficient product development lifecycle.
The Challenge:
The challenge was to implement a lean, intelligent and compliant Quality Management System to bring innovative medical devices from concept to clinical trials, and commercial approval in global markets. An efficient software solution was required to support the product development and manufacturing team.
The Solution:
CompanionQMS was identified as the standout software solution with an easy-to-use interface and capable of maintaining all Quality Documentation on an FDA 21 CFR Part 11 compliant platform. Developed and supported by experienced MedTech personnel, CompanionQMS training and system deployment was facilitated in just a few hours. The expert team in Perfuze are successfully maintaining the required legal compliance records for their innovative stroke treatment technology.
The Results:
Perfuze was awarded ISO 13485 certification for design and manufacturing systems. The team has received US FDA Breakthrough Designation Status for the Millipede Aspiration System, recognising the potential to offer significant advantages over existing alternatives for treatment of acute ischemic stroke. Perfuze has also received several regulatory clearances in the United States and Europe.
Perfuze is successfully continuing the commercial and product lifecycle journey, supported by CompanionQMS.
Danielle Hamilton
Danielle Hamilton
"CompanionQMS provides an easy-to-use platform that is ideal for early-stage companies when building a Quality Management System to suit their needs. The flexibility it provides facilitates efficiency during the product development cycle and can be adopted easily by both R&D and manufacturing teams alike."
How Rockfield Medical journeyed from concept
to US FDA 510(k) approval with CompanionQMS
The Opportunity:
Rockfield Medical Devices is a developer of innovative medical solutions which can transform the mobility and quality of life of enteral feeding users. Founder & CEO, Tomás Thompson, set out to deliver a new tube feeding system to the market.
The Challenge:
The challenge was to implement a lean, intelligent and compliant Quality Management System to bring innovative medical devices from concept to commercial approval in the US market. An efficient software solution was required to support the product and development team.
The Solution:
CompanionQMS was identified as software with an easy -to-use interface and capable of maintaining all Quality Documentation on an FDA 21 CFR Part 11 compliant platform. Developed and supported by experienced MedTech personnel, training and system deployment was facilitated in just a few hours.
Rockfield Medical assembled an expert team and created the QMS and Design History File necessary to facilitate a US FDA 510(k) submission and device approval.
The Results:
The patented system, Mobility+, is the first US FDA cleared elastomeric feeding pump which delivers enteral feed to the user. Operating independent of any electronics, it reduces technical support and maintenance costs for sales partners, disrupting the service models for enteral feeding pumps in the industry. Rockfield Medical is an FDA registered facility and is continuing the commercial and product lifecycle journey with CompanionQMS.
Tomás Thompson
Rockfield CEO
"We looked at many different Quality Management Systems and the research directed us to CompanionQMS. It is the right fit in terms of flexibility, ease of use and budget for Rockfield."