--- description: Ontdek de plus- en minpunten van qmsWrapper en leer meer over de functies, de prijs en het gebruiksgemak van de software. Lees nuttige beoordelingen van geverifieerde gebruikers en ontdek vergelijkbare programma's op Capterra België. image: https://gdm-localsites-assets-gfprod.imgix.net/images/capterra/og_logo-e5a8c001ed0bd1bb922639230fcea71a.png?auto=format%2Cenhance%2Ccompress title: qmsWrapper - Bekijk prijzen, reviews en scores - Capterra België 2026 --- Breadcrumb: [Startpagina](/) > [Kwaliteitsmanagementsystemen](/directory/30099/quality-management/software) > [qmsWrapper](/software/155171/qmswrapper) # qmsWrapper Canonical: https://www.capterra.be/software/155171/qmswrapper Pagina: 1 / 2\ Volgende: [Volgende pagina](https://www.capterra.be/software/155171/qmswrapper?page=2) > Kwaliteitsbeheersoftware voor makers van medische apparaten. > > Oordeel: score van **4.6/5** door 15 gebruikers. Hoge score voor **Waarschijnlijkheid van aanbeveling**. ----- ## Overzicht ### Wie gebruikt qmsWrapper? Voor startups en fabrikanten van medische apparaten die voor unieke uitdagingen staan met Design Control en Risk Management en streven naar naleving van CE-markering, FDA 510k of ISO 13485:2016. ## Snelle statistieken en scores | Metriek | Beoordelen | Details | | **In totaal** | **4.6/5** | 15 Reviews | | Gebruiksgemak | 4.2/5 | Gebaseerd op alle reviews | | Klantenondersteuning | 4.8/5 | Gebaseerd op alle reviews | | Prijs-kwaliteitverhouding | 4.5/5 | Gebaseerd op alle reviews | | Functies | 4.1/5 | Gebaseerd op alle reviews | | Aanbevelingspercentage | 80% | (8/10 Waarschijnlijkheid van aanbeveling) | ## Over de leverancier - **Bedrijf**: qmsWrapper - **Locatie**: Markham, Canada - **Opgericht**: 2015 ## Commerciële context - **Doelgroep**: Zelfstandig ondernemer, 2-10, 11-50, 51-200, 201-500, 501-1.000 - **Implementatie en platforms**: Cloud, SaaS, Web, Mac (desktop), Windows (desktop) - **Ondersteunde talen**: Engels - **Beschikbare landen**: België, Canada, Denemarken, Duitsland, Finland, Frankrijk, Ierland, India, Italië, Liechtenstein, Litouwen, Luxemburg, Nederland, Noorwegen, Oostenrijk, Pakistan, Polen, Portugal, Servië, Spanje en 6 meer ## Functies - Afwijkingen bijhouden - Apparatuurbeheer - Auditbeheer - Compliancebeheer - Corrigerende en preventieve maatregelen (CAPA) - Documenten coderen en controleren - Hoofdoorzaakanalyse - Incidentenbeheer - Klachtenbeheer - Kwaliteitscontrole - Onderhoudsbeheer - Projectplanning - Rapportage en statistieken - Rapportage/projecten volgen - Samenwerkingstools - Taakbeheer - Trainingsbeheer - Veranderingsbeheer ## Integraties (1 in totaal) - Jira ## Ondersteuningsopties - E-mail/helpdesk - Veelgestelde vragen/forum - Kennisbank - Telefonische ondersteuning - Chatten ## Categorie - [Kwaliteitsmanagementsystemen](https://www.capterra.be/directory/30099/quality-management/software) ## Gerelateerde categorieën - [Kwaliteitsmanagementsystemen](https://www.capterra.be/directory/30099/quality-management/software) - [Project management software voor de non-profitsector](https://www.capterra.be/directory/32439/project-management-software-for-nonprofits/software) - [Project management tools](https://www.capterra.be/directory/30002/project-management/software) - [CAPA-Software (Corrective and Preventive Action)](https://www.capterra.be/directory/31343/corrective-and-preventive-action/software) ## Alternatieven 1. [Jira](https://www.capterra.be/software/19319/jira) — 4.4/5 (15336 reviews) 2. [Zoho Projects](https://www.capterra.be/software/169455/zoho-projects) — 4.5/5 (859 reviews) 3. [Airtable](https://www.capterra.be/software/146652/airtable) — 4.6/5 (2227 reviews) 4. [Upwave](https://www.capterra.be/software/156630/upwave) — 4.6/5 (74 reviews) 5. [ClickUp](https://www.capterra.be/software/158833/clickup) — 4.6/5 (4572 reviews) ## Reviews ### "Very happy to have found, even happier to recommend\!" — 5.0/5 > **Jonathan** | *6 september 2017* | Medische apparatuur | Aanbevelingsscore: 10.0/10 > > **Pluspunten**: My company came from MasterControl; we found it hard to use, expensive, and essentially a giant version control system that was quite dated. For a long time we have to run project management separately in Asana, increasing our workload and, even after expensive MasterControl training, leaving us wondering what to do to get our medical device through the certification process. Then I found QmsWrapper QmsWrapper is not only a QMS system and a Project Management tool, but it actually has the processes and templates required to get you through ISO 13485 and an FDA510k build directly into it. This was clearly made by people who have not only been through the process, but recognised how hard it was and the need for a system to help guide one through it. Their support reflects this, as they understand your needs and go above and beyond helping you. The processes explain what you need to do, step by step, giving you templates to download, populate, and upload back into the system. Auditors don't just want to see that you have said you are going to do something, they want proof that you have done it - using QmsWrapper to do your project management, host your meetings, and have conversations in its inbuilt chat program, provide you with just that - proof. It even has an inbuilt quality manual that you configure to your companies needs. You can then run a gap analysis from what you have said you're going to do, and what you have actually done, to find the holes. > > **Minpunten**: They need a new desktop sync tool, which I believe they are working on, but the biggest issue with the system is that it does not interface with your local calendar. Meetings have to be scheduled all the time, with people on the go, and one must consider that the entire team does not sit in the system. It could also do with a traceability matrix, and better training videos / manuals. My account manager has been fantastic in lieu of this, and I have it on good faith that the matrix is on its way this month. > > Project management + QMS Processes to guide you through regulations Templates to populate Massively cost saving Wonderful account management Automated Quality Manual with a gap analysis report ----- ### "QA" — 5.0/5 > **Karen** | *14 december 2020* | Medische apparatuur | Aanbevelingsscore: 7.0/10 > > **Pluspunten**: For my job it is quite important to keep track of all documentation, including regulatory submissions. In the Storage you can see all the information on one particular document – who created, number of revisions, changes through revisions, who was the author of revision, when it was reviewed, when and which revision is approved, even the comments why the revision was declined. It takes a lot less time for showing the auditors what we did. > > **Minpunten**: It was a bit time consuming setting the system, and to understand what is the best way to organize our work. > > I admit, at the beginning, I was a bit reluctant when it came to using it, since we previously used paper-based system. But, slowly, I got to a point where I was proud of myself for managing my work through it. ----- ### "Outdated Software" — 1.0/5 > **Metehan** | *9 december 2020* | Medische apparatuur | Aanbevelingsscore: 0.0/10 > > **Pluspunten**: Easy to understand, Helpful team, Quick response and availability > > **Minpunten**: The software is outdated, its like an improved excel sheet, We are using jira/confluence day to day basis and qms wrapper is not even matching with them ----- ### "A complete beginner ..." — 5.0/5 > **Paddy** | *4 mei 2021* | Medische apparatuur | Aanbevelingsscore: 8.0/10 > > **Pluspunten**: As part of a very small startup medical device development company I was given the task of looking at compliance. While familiar with IT systems in general, I had zero QMS knowledge and experience, and indeed still coming to terms with the concepts and practice. At the start it would have been very helpful to have video tutorials and / or an overview diagram as to how the system works, but in their absence I ended up printing out the user manual and working my way through that and setting up a demo project to play with. I did come across a few bugs, but these were acknowledged when reported and hopefully addressed. When stumped, I had quick replies to any queries which was appreciated. From a purely IT perspective the level of integration and process / document control is impressive. > > **Minpunten**: I have started working on the quality manual "add-on", and while appreciating the approach being taken to use a template document integrated to the core product to permit an automated GAP report, the very limited word processing functionality in the design and amendment of the manual is for me a major issue, particularly as I am of an age where grammar matters and a document's look and feel is important. > > Coming from ground zero I think there needs to be more to help in getting started and in understanding the fundamental approach of qmsWrapper. Having said that, for someone with a little knowledge of quality management systems it may be much more intuitive. I am impressed with the level of integration and system stability, and apart from the odd minor change to programs from that which is documented in the Help Guide, I have not been able to break it yet. ----- ### "Quality Management Software review" — 5.0/5 > **Vladimir** | *8 november 2022* | Medische apparatuur | Aanbevelingsscore: 9.0/10 > > **Pluspunten**: Implementing the design controls and risk management activities is intuitive. qmsWrapper's Traceability Matrix helps us to develop device and to have Technical File with one click. When you have support like theirs, you don't have to worry about how your employees would accept working in software. > > **Minpunten**: When they have an upgrade, I often come across a bug that they fix in a few days. It really suits our needs and I can't single out bigger cons. > > I am satisfied with qmsWrapper, because it has all the necessary functionalities for successful management of QMS and product development. I would like to highlight that the organization in the company is much better than before. The price of the annual subscription is quite satisfactory. ----- Pagina: 1 / 2\ Volgende: [Volgende pagina](https://www.capterra.be/software/155171/qmswrapper?page=2) ## Links - [Bekijk op Capterra](https://www.capterra.be/software/155171/qmswrapper) ## Deze pagina is beschikbaar in de volgende talen | Locatie | URL | | de | | | de-AT | | | de-CH | | | en | | | en-AE | | | en-AU | | | en-CA | | | en-GB | | | en-IE | | | en-IL | | | en-IN | | | en-NZ | | | en-SG | | | en-ZA | | | es | | | es-AR | | | es-CL | | | es-CO | | | es-CR | | | es-DO | | | es-EC | | | es-MX | | | es-PA | | | es-PE | | | fr | | | fr-BE | | | fr-CA | | | fr-LU | | | it | | | nl | | | nl-BE | | | pt | | | pt-PT | | | sv | | | tr | | ----- ## Gestructureerde gegevens