qmsWrapper Blog
qmsWrapper Spring Update: Empowering MDR Compliance & Enhanced Security
Canada, May 22, 2023 - This comprehensive release introduces several key enhancements, including added process templates that are further supporting the Medical Device Regulation (MDR) and strengthened security measures. With these advancements, qmsWrapper is dedicated to helping medical device manufacturers navigate the complexities of changes from MDD to MDR compliance that has to be properly...
qmsWrapper in 2022
There is still a little time left until the end of 2022, so it is the right time to sum it up and set new goals for 2023.
qmsWrapper received another badge for Fall 2022
Autumn has arrived and with it another recognition from our clients, which they expressed through the G2 portal.
“High performer – Summer 2022” - qmsWrapper received another recognition from G2
qmsWrapper gets the badge "High Performer for Summer 2022" in the category Medical QMS Software.
QMS Tags
From now on, you don't have to think about whether all the documents and events relevant to your Audit have been prepared on time.
G2 Spring 2022 Grid® Reports Name qmsWrapper High Performer Medical QMS System
As the new year started, we’re delighted to announce qmsWrapper has been named High Performer in the G2 Spring Grid® Reports.
Upgraded Dashboard and QMS Control
qmsWrapper has developed a better way to access QMS functionality in qmsWrapper.
It’s a new UI or Dashboard, and QMS Control Tables.
qmsWrapper Notifications - included!
In order to get a faster response from your team, qmsWrapper notifies the assignee of the new task with a ringtone, in addition to email notifications.
ISO 9001 implementation: Mandatory documents and records
Find out what are the mandatory documents and records for the successful implementation of ISO 9001 in our article.
Wrapper File App – advanced editing and control of the documents
The Wrapper File App has empowered one of the most essential modules of any QMS software-Document Management. Find out how.
ISO 13485 implementation: Mandatory documents and records
Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS.
Software as a medical device - life cycle
The life cycle of the medical device is a development process of the product, from its beginning to the end.
Validation efforts
If you want to use secured and reliable software, this is what you must know about QMS software validation.
Remote audits – what are the limits?
A virtual audit is a method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence.
Benefits of remote auditing
Remote audits can have many benefits in terms of efficiency, access to competencies, increased reach and risk mitigation. Check out what the benefits might be.
Do remote audits becoming 'new normal'?
Remote audits refer to the use of information and communication technology for collecting information, questioning audited personnel, etc.
Continual Improvement and Nonconformity and corrective action – Lecture 24
Improvement means, in a way, finding the parameters that affect the realization of goals and submitting them to change.
Management review – Lecture 23
It is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness.
Internal audit – Lecture 22
The internal audit is one instrument for self-review of whether requirements are achieved. More in our next lesson.
Monitoring measurement, analysis, and evaluation – Lecture 21
This part of the ISO 9001:2015 is critical for assessment of the performance of your QMS. Find out more about monitoring, measurement, etc.
Control of Nonconforming Outputs – Lecture 20
Controlling the nonconforming outputs will allow you to minimize their effect, map the problem, and track down the root cause – learn more with qmsWrapper.
Release of products and services – Lecture 19
Release of the product or services is about verification that the product and service requirements have been met according to customer requirements.
Production and service provision – Lecture 18
Learn how to control, identify and preserve production and service provision according to ISO 9001:2015, with qmsWrapper.
Control of externally provided processes, products, and services – Lecture 17
It all varies widely depending on the nature of the processes, products, and services.