Medical Device QMS Software

Medical Device QMS Software

par Greenlight Guru

Pour qui ?

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.

Notes moyennes

59 avis
  • Note globale 4.5/5
  • Facilité d'utilisation 4.3/5
  • Service client 4.8/5
  • Fonctionnalités 4.2/5
  • Rapport qualité-prix 4.4/5

Informations sur le produit

  • Version gratuite Non
  • Essai gratuit Non
  • Déploiement Cloud, SaaS, web
  • Formation Formation en ligne en direct
    Webinaires
    Documentation
  • Ressources d'aide Service de support permanent (réponse directe)
    Support en horaire de bureau
    En ligne

Informations sur l'éditeur

  • Greenlight Guru
  • http://greenlight.guru
  • Fondé en 2013

En savoir plus sur 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 - Fonctionnalités

  • Analyse des causes profondes
  • Contrôle de qualité
  • Gestion de la formation
  • Gestion des audits
  • Gestion des changements
  • Gestion des incidents
  • Gestion des plaintes
  • Gestion des risques
  • Planification des mesures correctives (CAPA)
  • Suivi des non-conformités
  • Contrôle des documents
  • Contrôle qualité des fournisseurs
  • Gestion de la conformité
  • Gestion de la formation
  • Gestion de la maintenance
  • Gestion des audits
  • Gestion des normes ISO
  • Gestion des plaintes
  • Gestion des risques
  • Gestion des équipements
  • Logiciels d'actions préventives et correctives
  • Suivi des problèmes

Avis les plus utiles sur Medical Device QMS Software

A god-send of a QMS

Publié le 11/12/2018
Sarah K.
President & Chief Operating Officer
Hôpitaux et soins de santé, 2-10 employés
Temps d'utilisation du produit: plus d'un an
Provenance de l'utilisateur 
5/5
Note globale
5/5
Facilité d'utilisation
5/5
Fonctionnalités
5/5
Support client
5/5
Rapport qualité-prix
Probabilité de recommander le produit :
Très faible Très élevée

Commentaires: 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.

Avantages: 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.

Inconvénients: 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.

Réponse de l'éditeur

envoyé par Greenlight Guru le 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.

Truly Turnkey, Great for new companies

Publié le 06/01/2020
Vineet E.
COO
Appareils médicaux, 13-50 employés
Temps d'utilisation du produit: plus d'un an
Provenance de l'utilisateur 
4/5
Note globale
4/5
Facilité d'utilisation
4/5
Fonctionnalités
5/5
Support client
4/5
Rapport qualité-prix
Probabilité de recommander le produit :
Très faible Très élevée

Commentaires: Greenlight.Guru has allowed us to, from a very young, inexperienced stage, build from scratch an easy to use and comprehensive quality system that has passed external audit with ease. The customer support, user interface, and turnkey solution offered by Greenlight.Guru has exceptionally useful for us, and been the foundation for Quality Management at our company.

Avantages: Using Greenlight.Guru, we were able to build a quality system from scratch quickly that met our needs without the headache of complicated set-up and configuration. This tool enabled us to go from nothing to passing our first audit with confidence and ease. Great tools to link design and risk with documents and approvals. The customer service was also great, and Greenlight helped build our knowledge of Medical Device Quality at the beginning of our company's life, allowing many of us to rise from inexperience to competence to near mastery of quality systems. Greenlight further offers an unparalleled user interface and intuitive tools that make using it a cinch for almost all employees at our company.

Inconvénients: Understanding best practices can be a bit challenging and time consuming given that there is one standard offering for all customers and customization is intentionally not available. Being a new company, Greenlight has grown with us. Some features that would have been nice to have earlier were developed and pushed during our use of the software, though it is clear that the product is maturing to meet the needs of its customers without sacrificing the ease of use.

Greenlight Guru for OtoNexus

Publié le 01/12/2016
Grant J.
Provenance de l'utilisateur 
4/5
Note globale
4/5
Facilité d'utilisation
4/5
Fonctionnalités
4/5
Support client
4/5
Rapport qualité-prix

Commentaires: I am a consultant, working with OtoNexus, an early-stage medical device company, on the implementation of their Quality Management System (QMS). We advised them to consider deploying Greenlight Guru for this purpose, and they are in the initial stages of doing so. The Document Management features of the software appear to be thorough, well thought out and useable. Obviously, the flexible routing and detailed history features for document review and sign-off, and compliance with Part 11, are very helpful and key to the success of any medical device company's QMS. The tutorial on the Product Development module, which is based on 14971 risk management principles, seems like it will be an excellent tool. Unfortunately, the client is a bit behind in utilizing it, and wants some other project management features implemented that, frankly, are a bit beyond the scope of this type of software tool. Customer support in general has been excellent. We have noted, however, that when product feedback is given, although the response to a question or issue is timely, there is often a defensive tone that comes across. An example of this was when there was a change to the software, which caused a conflict with login using a browser that had worked fine previously. Yet, we were not notified of this change, and once we found the issue, were told to update our browser. This software, like any other, is imperfect, and can and should be continuously improved. Overall, my initial impressions are that this is an excellent software tool for implementing a QMS at a medical device company.

Réponse de l'éditeur

envoyé par Greenlight Guru le 17/12/2018

Hi Grant, thank you for taking the time to write your review of greenlight.guru.

You input, and the feedback from all our customers is very important to the continuous improvement of our software.

Since your original feedback on 12/1/16, we've evolved our internal release processes and documentation in order to assure changes such as this are better communicated with customers.

Thanks again for your feedback and partnership.

More functionality preferred

Publié le 15/11/2016
Dieu W.
Quality Manager
Appareils médicaux, 13-50 employés
Temps d'utilisation du produit: plus de deux ans
Provenance de l'utilisateur 
3/5
Note globale
4/5
Facilité d'utilisation
2/5
Fonctionnalités
5/5
Support client
3/5
Rapport qualité-prix
Probabilité de recommander le produit :
Très faible Très élevée

Commentaires: Overall the software is easy to use, but there are a few functionality that we wish were there, specifically:
- parallel approvers
- ability to attach redlines as part of routing (and then ability to publish clean copy); now it forces you to review redlines offline (not great since it gets lost in people's email, etc.)
- ability to reassign who can publish the document (if person who routed it is out and doc control/quality should be able to publish for them).
- ability to turn on email notifications if you have something in your inbox

Avantages: online

Inconvénients: very limited functionality

Réponse de l'éditeur

envoyé par Greenlight Guru le 14/12/2018

Hello, Dieu. Thank you for your feedback. We heard you, loud and clear.

As a result of your feedback, we've added parallel routing and the ability to include redlines and mark-ups to review and approval workflows.

Additionally, we've since enabled user level email notification preferences for you to better control the types of messages you'd like to receive via email.

Initial Review

Publié le 01/04/2019
Art M.
Chief Operating Officer
Appareils médicaux, 2-10 employés
Temps d'utilisation du produit: 1 à 5 mois
Provenance de l'utilisateur 
5/5
Note globale
5/5
Facilité d'utilisation
5/5
Fonctionnalités
Support client
Rapport qualité-prix
Probabilité de recommander le produit :
Très faible Très élevée

Commentaires: To date, GG has been an excellent partner in the implementation of an otherwise difficult system.

Avantages: We set out to implement a QMS for our small Medical Device Company. To date, Greenlight Guru (GG) has proven to be an excellent choice. We are only a few months into the process but I see no problem in staying on track. Their support has been fantastic! We are ahead of schedule and I have been pleased with the quality of support we are getting. Our company has had a few false starts with consulting firms, GG is making the process enjoyable.

Inconvénients: GG offers a package of procedure templates that make the job much easier. With that, the formatting and wording of the templates could be a tad more uniform. With that said, it is understandably difficult to make a universal set of templates that fit everyone's needs. I find the template package well done on that front.

Réponse de l'éditeur

envoyé par Greenlight Guru le 10/04/2019

Hey Art -

Our team greatly appreciates you taking the time to provide your feedback. We are thrilled to hear that our Customer Success team's Fanatical Support has jumpstarted your implementation process, while also making it an enjoyable experience.

We appreciate your feedback regarding our procedure templates, as well. Please feel free to share your ideas for improvement with a member of our team.

Thanks again - Glad to have you as a customer of Greenlight Guru!

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