Wer nutzt diese Software?

Greenlight Guru is the perfect solution for medical device companies looking to save time and money bringing their product to market. Our customer include QA/RA roles, Engineers and Executives alike.

Durchschnittliche Bewertung

57 Bewertungen
  • Gesamt 4.5 / 5
  • Benutzerfreundlichkeit 4.3 / 5
  • Kundenservice 4.8 / 5
  • Funktionen 4.2 / 5
  • Preis-Leistungs-Verhältnis 4.4 / 5

Produktinformationen

  • Kostenlose Version Nein
  • Gratis Testen Nein
  • Einsatz Cloud, SaaS, Web
  • Training Live Online
    Webinare
    Dokumentation
  • Kundenbetreuung 24/7 (Live Vertreter)
    Support während der Geschäftszeiten
    Online

Angaben zum Hersteller

  • Greenlight Guru
  • http://greenlight.guru
  • Gegründet 2013

Über Medical Device QMS Software

Greenlight Guru is the only electronic Quality Management Software (eQMS) designed by MEDICAL DEVICE PROFESSIONALS specifically to meet the unique NEEDS OF MEDICAL DEVICE COMPANIES. Our comprehensive, out-of-the-box solution is based on the latest FDA and ISO standards and best practices, all of which are meticulously woven into every feature within the cloud-based platform. Join hundreds of other medical device companies working with us to shift your focus from just compliance to True Quality.

Medical Device QMS Software Funktionen

  • Beschwerdemanagement
  • CAPA-Planung
  • Nachverfolgung von Nicht-Einhaltungen
  • Qualitätskontrolle
  • Risikomanagement
  • Störfallmanagement
  • Trainingsmanagement
  • Ursachenanalyse
  • Veränderungsmanagement
  • Wirtschaftsprüfung-Management
  • Beschwerdemanagement
  • Compliance Management
  • Corrective and Preventive Action (CAPA)
  • Dokumentenkontrolle
  • Geräte-Management
  • ISO-Standard-Management
  • Instandhaltungsmanagement
  • LieferantenQualitätskontrolle
  • Risikomanagement
  • Trainingsmanagement
  • Verfolgen von Fehlern
  • Wirtschaftsprüfung-Management

Die hilfreichsten Reviews für Medical Device QMS Software

Great software to implement and maintain a medical device QMS

Bewertet am 5.11.2018
Jason C.
Project Engineer
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Quelle des Nutzers 
5/5
Gesamt
5 / 5
Benutzerfreundlichkeit
5 / 5
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
5 / 5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: Overall experience is great. As a small medical device company, I can't imagine keeping up with our QMS requirements without a software platform like Greenlight Guru.

Vorteile: The design trace matrix makes the development process very straight forward and easy to use. The ability to link anything to each DTM component, and to link the DTM to the risk management module is great as well. The document management and routing/approval features are also a great tool. We've been able to implement digital versions of most of our work forms, without the need to use third party document signature programs.

Nachteile: Sometimes there is a bit of a learning curve for the various modules that they release. It would be nice if a help/guide button was available for each to walk through the module step by step.

Antwort des Softwareanbieters

von Greenlight Guru an 17.12.2018

Hey Jason:

Thank you for the positive comments and feedback.

Glad to hear that the ability to Link Anything is positively impacting your Design Control/Risk efforts and that built in workflows with eSignatures are simplifying processes.

As it relates to your feedback on getting up to speed on how to use new functionality, know that we've heard you and are actively working on a solution to help you get up to speed on how to use new functionality and what's changed in app that I believe you will be pleased with.

Don't ever hesitate to share additional feedback like this with us by phone, chat, or email at customer.success@greenlight.guru

Medical device startup's experience

Bewertet am 15.11.2016
Matthew B.
Co-founder / CTO / QA/RA
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Quelle des Nutzers 
5/5
Gesamt
4 / 5
Benutzerfreundlichkeit
3 / 5
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
5 / 5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: greenlight.guru is the perfect software solution for a medical device startup company looking to get a quality management system, compliant with both the FDA's and ISO's requirements, up and running. It also holds your hand through the design control and risk management process, which is especially valuable for a company without much experience going through these processes. We didn't need to hire a quality manager because of how helpful this software is, a fact that alone makes it worth the price.

Vorteile: The structure of the design control and risk management modules guide you through the process of documenting both. Especially great for someone who's never gone through these processes before.

Nachteile: While it contains the core of what's necessary for a QMS, it lacks a lot of functionality that a larger business would need, making it likely that we'll outgrow it quickly.

Antwort des Softwareanbieters

von greenlight guru an 5.12.2016

Hi Matthew, we appreciate you taking the time to write your review of our software.

That's great to hear greenlight.guru has enabled you to delay the hire of a full time quality manager.

Per your comment regarding the feature set needed for a larger business, we'd love to hear your specific recommendations if you have them so that we can take them into account as we continue to execute on our roadmap.

You can reach out to us and provide your feedback directly to customer.success@greenlight.guru.

To date, we have several larger medical device companies with multiple products and hundreds of employees that are successful using the platform.

Great product, continuously improving!

Bewertet am 12.12.2018
Stephen P.
Lead Quality Engineer
Design, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
5 / 5
Benutzerfreundlichkeit
5 / 5
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: We needed an eQMS system, and a method of tracking our project progress. Greenlight.Guru does that in a fluid, comprehensive manner - making my life far easier.

Vorteile: Greenlight.guru successfully ties risk analysis to design controls, providing a method of reviewing all of the design or component by component. All of the associated documents can be linked to Design items, weaving in the entire story behind a particular product. I have not found a similar product, and have never seen a more dedicated team. Issues that I have encountered, they resolve in a thoughtful, forward-thinking manner.

Nachteile: In the early usage, there were difficulties finding the documents I wanted. They have recently added the linking functionality on the document side, which allow related items to be tied to each other.

Antwort des Softwareanbieters

von Greenlight Guru an 17.12.2018

Hey Stephen,

Thank you for the kind feedback. The team at GG is dedicated to assuring the success of our customers.

Glad to hear the linking functionality is benefiting your efforts. Additionally, I think you'll be pleased with upcoming efforts we are making to further simplify document management starting with the debut of Document Views in our December release.

Keep the feedback coming.

Recommendation for Greenlight Guru as your medical device eQMS solution

Bewertet am 23.10.2018
Penny N.
CEO
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Quelle des Nutzers 
5/5
Gesamt
5 / 5
Benutzerfreundlichkeit
5 / 5
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
5 / 5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: Ease of integration of design control with risk management is a breeze. No more tedious xcell spreadsheets!!

Vorteile: I like that this medical device software is built by medical device professionals and not just SW developers who don't even know what a medical device is! this SW is built to match the processes I have been doing now for over 35 years - document control, design control, capa, internal audits, etc. Both modules GO and GROW are on spot to meet the regulatory requirements.

Nachteile: As with any SW we have to be methodical in our naming conventions as we load documents. Its all about setting rules as a company so that SMART naming is followed which makes the search mechanisms more effective.

Antwort des Softwareanbieters

von Greenlight Guru an 1.11.2018

Hi, Penny.

Really appreciate your feedback and comments.

Did you know that all documents are assigned a unique ID when added now? Yes, there is still a need to apply some intelligence with document naming and description. Those attributes (regardless of system) are key.

A god-send of a QMS

Bewertet am 11.12.2018
Sarah K.
President & Chief Operating Officer
Krankenhausversorgung & Gesundheitswesen, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Quelle des Nutzers 
5/5
Gesamt
5 / 5
Benutzerfreundlichkeit
5 / 5
Eigenschaften & Funktionalitäten
5 / 5
Kundenbetreuung
5 / 5
Preis-Leistungs-Verhältnis
Wahrscheinlichkeit der Weiterempfehlung:
Unwahrscheinlich Äußerst wahrscheinlich

Kommentare: As a new medtech company with many different product and differing product regulations, we are pleased to have Quality Management as one of our easiest tasks - which is rare to say. The team is fantastic and abundantly helpful, the system is quick to learn and easy to use, and the support you get standing the system up from scratch if you don't already have a system in place is great. We needed Quality "handled" so we could focus on the trickier parts of our company - Greenlight Guru was and is that perfect solution.

Vorteile: With GG, it is structured and organized to not just allow compliance, it promotes compliance - meaning using the software as it is built easily documents for product design/dev and ongoing quality req'ts. It's easy to use and navigate, quick to learn even for lay people, and makes our QMS regulatory headache-free.

Nachteile: The team keeps making improvements, and I'm looking forward to a bit of a better structure to the large document repository. It is searchable, tagable, and sortable easily, but there are a few other ways that they could organize things so you can find something quickly.

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Hi Sarah,

The team at GG greatly values your feedback and we appreciate you taking the time share your experience working with our software and team.

Glad to hear you are excited about the upcoming enhancements to Advanced Document Management with with debut of Document Views in our December 2018 release.

We strive to simplify quality management for medical device companies of all sizes, and welcome any future feedback or enhancements ideas.

Lies weitere Bewertungen