What MedTech Innovators are Saying About Grand Avenue Software
“Grand Avenue’s suite of quality system modules make record-keeping and compliance quick and easy. The modules are easy to customize and intuitive for users. Customer service is top-notch!”
Customer: Laura Bauer
Company: Enterra Medical
Company Size: 51–100
Market Stage: Post-Market
Type of Device: GI Therapy
Class of Device: HDE
“Our experience working with the Grand Avenue Software (GAS) team has been absolutely wonderful! Their out of the box solution and ease in configuring our needs has been the highlight of our experience. GAS has enabled us to exponentially reduce our time spent in the manual processes for controlled documents and training management.”
Customer: Dhruti Sheth
Company: Induce Biologics
Company Size: 1–20
Market Stage: Post-Market
Type of Device: Orthobiologics
Class of Device: N/A
“Grand Avenue is very intuitive – it is easy to use, very easy to configure, and enables consistent compliance with FDA, ISO, and GxP.
Customer: Lisa Huddle
Company: Eximis Surgical
Company Size: 1–20
Market Stage: Post-Market
Type of Device: Specimen Collection
Class of Device: N/A
“We have greatly reduced the processing, review and approval times for document creation and revision. In addition, we have been able to move some older paper processes to a fully digital process within Grand Avenue.”
Customer: Chris Karow
Company: Anteris Technologies
Company Size: 101–200
Market Stage: Pre-Market
Type of Device: Cardiac
Class of Device: Class III
“We chose GAS due to the quick responses, customer service, and reasonable fee structure. The support from the start was top rate. It has been a great experience for our company.”
Customer: Laurie Hayner
Company: Coramaze
Company Size: 21–50
Market Stage: Post-Market
Type of Device: Cardiac
Class of Device: Class III
“Benefits:
- organized, controlled, documents
- audit trail of changes
- prompts to ensure updates are completed
- easy access for training and use
- cost effective especially for a small company
- superior customer service
- ongoing training made available about how to use the system
- customized system modules designed to support users
What more can I say? I really enjoy using Grand Avenue Software to support my team.”
Customer: Joy Frestedt
Company: Frestedt
Company Size: 1–20
Market Stage: Post-Market
Type of Device: Design & Engineering
Class of Device: Class III
“Grand Avenue is a robust and comprehensive tool for meeting regulatory requirements and managing processes. Before using its modules, I spent a lot of time managing records, reaching out to the right people, and—most importantly—completing and closing tasks. The Grand Avenue modules have significantly reduced the time I spend on these activities, making it easier to create and maintain accurate records while providing a clear overview of task statuses.”
Customer: Eyal Ozeri
Company: Flight Medical
Company Size: 1–20
Market Stage: Post-Market
Type of Device: Respiratory
Class of Device: Class II
“GAS is an easy-to-use eQMS software, and if you have any questions, their support is wonderful. They get back to you ASAP.”
Customer: Susan Kaltinger
Company: Microbiologics
Company Size: 201–500
Market Stage: Post-Market
Type of Device: Microbiological Control Products
Class of Device: Class I
“While working toward our ISO 13485 certification, our quality consultant highly recommended Grand Avenue to help streamline the process. Grand Avenue was instrumental in achieving our certification and has been excellent in keeping our documentation compliant and well-managed.”
Customer: Luke Lundquist
Company: Laser MedTech
Company Size: 1–20
Market Stage: N/A
Type of Device: Contract Manufacturer
Class of Device: N/A
“Checkpoint was looking for a modern, affordable document and learning management system. After comparing a few options, we selected Grand Avenue. Since that selection 3 years ago, we have been thrilled with the product, its hosted availability, and the responsiveness of the staff. We highly recommend this software to others that are smaller (~50-100 employees) companies!!!!”
Customer: Matt Hildebrand
Company: Checkpoint Surgical
Company Size: 51–100
Market Stage: Post-Market
Type of Device: Nerve Care
Class of Device: Class II
“The implementation of Grand Avenue Software was a game changer for us. The support we received in setting it up was invaluable, as is the ongoing customer support and learning tools.”
Customer: Alison Robeck
Company: Wilson Wolf
Company Size: 21–50
Market Stage: Post-Market
Type of Device: Cell & Gene Therapy
Class of Device: Class I
“Overall having a QMS to house all our documents has been lifesaving. We were manually keeping document control which was overwhelming. Grand Avenue has simplified so many things for us. It’s a life saver.”
Customer: Sandy McLaughlin
Company: Antylia
Company Size: 101–200
Market Stage: Post-Market
Type of Device: Environmental Sampling Equipment
Class of Device: N/A
“The modules have helped tremendously in allowing proper documentation to be completed on time and by personnel not based in Minnesota. Chitogen has used Grand Avenue Software modules for Design Control, Document Control and CAPA for about 10 years.”
Customer: Dave Senogles
Company: Chitogen
Company Size: 1–20
Market Stage: Post-Market
Type of Device: Hemostatic
Class of Device: Unclassified (Pre-amendment)
“Grand Avenue contains a lot of functionality. The way everything is task based is a great way to stay organized. The file content document search function is very useful. I’m always impressed with how quick it is too.”
Customer: Ethan Johnson
Company: Virtual Incision
Company Size: 51–100
Market Stage: Post-Market
Type of Device: Surgical Robots
Class of Device: Class II
“We are most satisfied with the quick and helpful responses, service and ease of use. The training from GAS helps us a lot.”
Customer: Enav Tuval
Company: Safeguard Medical
Company Size: 51–100
Market Stage: Post-Market
Type of Device: Emergency Medical & Trauma
Class of Device: Class I
“Straight- forward, easy to use tool for quality system related processes.
Nicely streamlined and audit-proof.
Traceability and links between processes helps connect interfaces and provide for transparency.
Clear and Structured approach.
With Grand Avenue, we managed to digitalize our QMS almost completely. It helped us complete the FDA initial establishment inspection without finding, afterwards got us through MDSAP certification as well as EU MDR certification without major issues.”
Customer: Florian Peters
Company: Path Medical
Company Size: 21–50
Market Stage: Post-Market
Type of Device: Audiological and Vestibular Diagnostic Equipment
Class of Device: Class II
“I have primarily used the Document Control and Training Management modules, which provide a robust, compliance-driven solution for managing documents and training. The system is well-structured and focused on compliance. Configuration is easy, as GAS has pre-validated the settings, ensuring a smooth and hassle-free setup.”
Customer: Nuzhat Hussain
Company: Induce Biologics
Company Size: 1–20
Market Stage: Post-Market
Type of Device: Orthobiologics
Class of Device: N/A
“In our medical company, efficient management of documents and certifications is essential to ensure regulatory compliance and quality in our processes. Implementing Grand Avenue Software has been a strategic decision that has transformed the way we manage documentation and regulatory requirements.
Since its implementation, we have seen a significant improvement in document control, ensuring that each version is properly recorded and accessible to the relevant teams. The automation of workflows has helped us reduce errors, optimize time, and ensure that every document meets the standards required by regulatory bodies such as the FDA and ISO 13485.
Additionally, the platform has made it easier to manage certifications, ensuring that records are always up to date and readily available for internal and external audits. Its intuitive interface and customization capabilities have enabled quick adoption by our teams, improving traceability and operational efficiency.
Grand Avenue Software has been a key tool in strengthening our quality management system, providing security, organization, and compliance in a highly regulated environment.”
Customer: Iram Almazan
Company: Centerpiece
Company Size: 51–100
Market Stage: N/A
Type of Device: Contract Manufacturer
Class of Device: N/A
“Grand Avenue is a powerful and user-friendly tool for managing and tracking NCMRs, CAPAs, complaints, SCARs, DCRs, and audits. Its intuitive interface and easy setup allow for quick implementation without complex processes.
One of its biggest advantages is its ability to track the status of each task in real time, ensuring efficient management of corrective and preventive actions. Additionally, its user-friendly design enhances collaboration across departments, improving visibility and control over quality processes.
Another major highlight of Grand Avenue is its excellent customer service. Their support team is responsive, professional, and always ready to assist, ensuring a smooth and hassle-free user experience.”
Customer: Mayra Rodriguez
Company: Centerpience
Company Size: 51–100
Market Stage: N/A
Type of Device: Contract Manufacturer
Class of Device: N/A
“Grand Avenue is a vast improvement over our previous eQMS in that it includes an Equipment Management module, a Risk Module, and Audit module. This allowed us to be fully paperless instead of having to utilize a hybrid system in the past.
Additionally, the Audit Trail function has been a life saver when trying to determine when something was changed and by whom and also the exact timing of training tasks.”
Customer: Andrew Ureno
Company: Life Science Outsourcing
Company Size: 101–200
Market Stage: N/A
Type of Device: Contract Manufacturer
Class of Device: N/A
“Grand Avenue Software was a fantastic platform for Intricon to move from a primarily paper-based Quality Management System (QMS) to an electronic platform. All of the modules cover our QMS needs as a Contract Manufacturer in the medical device space. The user interface is easy to navigate for all levels of our organization and the support from the Grand Avenue Software team made our start up as easy as possible.
The reporting and tracking features of GAS streamlines our internal and external audits, and has made our ability to ensure compliance to ISO 13485 and CFR Part 820 more streamlined and effective.”
Customer: Craig Sandbulte
Company: Intricon
Company Size: 501–1000
Market Stage: N/A
Type of Device: Contract Development & Manufacturing
Class of Device: N/A
“My company uses hundreds of controlled documents, and the Grand Avenue document control module has been an affordable option which allows us to manage the process of document control. I appreciate the control that Grand Avenue gives its users over every aspect of the software. Also, we have found many useful applications for the document collection feature and the additional documents feature.”
Customer: Delcie Kestner
Company: MagBio Genomics
Company Size: 1–20
Market Stage: Post-Market
Type of Device: Biologic Reagents
Class of Device: ClassI