Quality excellence for a medtech consultancy - and their clients
Switzerland-based Effectum Medical acts as a legal manufacturer, QMS consultant and Swiss Authorized Representative to accelerate access to the European markets for its diverse range of medical device clients. Effectum Medical is highly engaged in the start-up field and aims to promote innovation and best practice early in the development of client companies.
By offering a mixture of consultancy and a 'plug-and-play' digital QMS document set, the Effectum team of medtech experts helps their customers hit the market and embed lasting compliance with the EU's MDR and IVDR.
The Effectum Medical team is small, but combines a complex grouping of administrative, quality, regulatory, supply chain and product design/development departments.
Prior to the move to an eQMS, the company's quality management system was largely manual, driven by wet signatures, email, and manual training record generation.
The company wanted to strengthen and accelerate Effectum's operation. A small improvement was achieved by switching to DocuSign for electronic signing of documents, but the execution of DocuSign processes remained time-consuming and further digitization was desired.
It was clear that a dedicated electronic quality management system (eQMS) was required - and increasingly requested by Effectum's tightly regulated medtech clients.
There were more and more companies using eQMS platforms, and our customers were beginning to ask us if we were using one.
The expectation of our customers was that we'd be using a state-of-the-art quality management system.
And the tools we use are a factor in whether they work with us or with somebody else.
As a small company, Effectum Medical needed a cost-effective eQMS designed for SMEs.
They also had a unique use case: they wanted an eQMS to optimize their own quality activities, but also to share with and offer on to Effectum clients to help them get to market with a robust quality set-up of their own.
Several solutions were assessed by usability, cost and functionality. A clean, user-friendly eQMS, which could let Effectum Medical clients manage quality but not see the private information of other clients, was vital.
Effectum underwent a thorough vendor search to find the most suitable solution, including multiple review and testing loops of both eQMS and requirements engineering platform providers.
Qualio emerged as the clear platform of choice, and the company went live with the system in July 2023.
Effectum Medical began by moving their quality management processes, including suppliers, training and events (like change requests, non-conformities and CAPAs) into Qualio.
Medical device technical documentation (TD) is to be migrated in a second step, allowing Effectum to start using the system without the timing constraints that come with ongoing TD reviews by notified bodies.
The time savings and efficiencies provided by Qualio have immediately helped make Effectum's processes leaner.
Qualio Training has removed the requirement for planning and creating training records manually, while providing instant visibility of employees' training status.
Other benefits such as leaner document approval processes, fully native document collaboration, and end-to-end quality event management have all combined to augment the effectiveness of Effectum's QMS.
Qualio Design Controls, too, unlocked automatic generation of traceability matrices, eliminating a time-consuming manual task.
Instead of us doing manual training records, it's all automated. That's a huge benefit.
We've saved hours every single week managing documents.
And our event management - nonconformities, CAPAs, complaints - has gotten much more efficient.
Managing them is done in half the time, or less. It's brilliant.
Not only that, Qualio allowed Effectum to hit their planned goal of sharing a connected, digital quality system with customers.
Shared information, including SOPs, can be accessed by clients from Effectum's main 'parent' system - while individual client 'child' systems house confidential documents relevant only to that client, such as technical product information and events.
The partnership also enables Effectum customers to access combined, best-in-class support for eQMS set-up/management and technical document creation.
And with their faster, sharper quality approach in place, Effectum Medical are now keen to harness new Qualio functionality, including AI, as it's rolled out in the near future.
.png?width=20&height=20&name=Icons_Newsletters%20(3).png){kind=icon}
