qmsWrapper
3 Reviews 5/5 ★ ★ ★ ★ ★A unique QMS Software for startups and small companies seamlessly integrated into all essential functions.
qmsWrapper is a VALIDATED Medical QMS System purpose built to facilitate compliance with standards ISO 13485, ISO 14971, 21 CFR part 11, ISO 9001 and regulations enacted by the FDA. The solution is very complete including:
- Document
- Project
- Quality
- Risk
- Training
- CAPA
- Change
- Complaint
- Supplier
- Audit
- Nonconformity Module
- Traceability Matrix for DHFs
- inbuilt Team Messaging
- Processes
- Procedure Templates
- Quality Manual
- Forms
- Jira integration.
Video Overview
qmsWrapper is reliable, secure, flexible, and affordable even for startups. qmsWraper is a cloud-based QMS using the latest technology and powerful feature set has transformed the quality management systems of 800+ Companies into a collaborative and paperless environment for continual improvement.
qmsWrapper Features
qmsWrapper is primarily intended for startups and small and medium-sized companies that want to implement and maintain a QMS (according to ISO 13485 and ISO 9001). Therefore, the basic module is a Quality Management module which, with the integration with Project Management, enables the perfect way of functioning of the company.
qmsWrapper Target Market
Startups, small and medium-sized companies, MedDev companies, and companies that wants to implement ISO 9001.
qmsWrapper Pricing
The pricing is for annual subscription. Basic Package starting from $165/month/25 users + 1GB, providing access to ALL MODULES and services for ALL USERS from Day 1, as well as lifetime in-house support.
They offer 4 packages for MedDev QMS and for ISO 9001. Price depends on number of users. For example: 25 users for one year can will pay $125/month for ISO 9001, and $165/month for MedDev QMS. The subscription is annual.
Product Overview
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User Reviews of qmsWrapper
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We have solved many things in the company, and one of them is better organization.
qmsWrapper makes workflows easy to manage. I really like change control, automatically recorded data, and flexibility. You can create as many projects as you want, regardless of whether they are QMS related or not. You get the process templates free (ISO 13485, ISO 14971), and you only need to adapt them to your company. The same applies to forms used as “tasks”. They are great if you need reports on a monthly, quarterly, annual basis. There are many features I would like to highlight, but this is it for now. I would just like to point out that the support is excellent. In addition to documentation, enamels, video trainings for users are also possible.
The system is complicated for those who have never used software of this type.
The structure of the design control and risk management modules guides you through the process of documenting both. Especially great for someone who’s never gone through these processes before.
It is the perfect software solution for a meddev 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.
Export can be a problem sometimes, but as I know, they are fixing that.
Perfect for small companies
Quality, Project and Document Management Module. All Modules are connected, as well as our team. We manage all projects through qmsWrapper, not just QMS-related.
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