QMS Improvement and Gap Analysis
Labquality can help medical device manufacturers continually improve their quality management system (QMS). This includes updating the QMS e.g., when corrective and preventive actions are needed, revised standards are published, or regulatory landscape is changing.
But not only QMS, also medical device technical documentations need sometimes to be analysed for compliance, for example due to regulatory landscape changes or due to entering to new market areas.
Success in quality management
There are times when quality management system needs some update. Minor updates typically occur all the time with the principles of continuous improvement, but larger updates relates often to entering new areas in the world, regulation or standard updates, product portfolio updates, new business areas or company mergers. All these situations need systematic approach. Regulations and QMS standards require that QMS must be maintained, kept up to date and continually improved.
Labquality experts can support in this by evaluating the need for changes and perform documented GAP analyses against any set of requirements, for QMS or medical device technical documentations.
Labquality
How can we help?
Labquality can help manufacturers in maintaining and improving their QMS by:
- Identifying the changes that trigger QMS updates
- Preparing a systematic Gap Analysis for the existing QMS process(es) in relation to the change
- Helping the manufacturer to interpret the Gap Analysis and fill in the identified gaps in their QM
- Perform GAP analysis for the medical device technical documentations.
QMS Gap Analysis
Examples of QMS Gap Analysis we have been working on:
Contact us for more information
Leave a contact request
Related Services
US FDA 21 CFR Title 820 (QSR)
Labquality has great expertise with quality systems, including the USA Food and Drug Administration Quality System Regulation, QSR, 21 CFR Title 820.
Quality Management System ISO 13485
Labquality provides medical device manufacturers help with setting up quality management systems (QMS).
Latest news
Meet us in Tomar, Portugal
Labquality will attend SPML's (Sociedade Portuguesa de Medicina Laboratorial) 16th scientific meeting in Tomar, Portugal, from 12 to 13 April 2024.Meet us at ECCMID in Barcelona
Visit our booth E5 in the ECCMID exhibition and hear about EQA services for microbiology, as well as CRO services for pharmaceuticals and MD/IVD manufacturers.Why Modeling Data Flows Is Needed in Clinical Investigations
data management manager explains how data flow modeling will help keep clinical investigation stakeholders informedEQA Coordinator Anna-Riitta Vanhanen Retires After 34 Years of Service
EQA Coordinator Anna-Riitta Vanhanen is retiring in the autumn of 2024 after working at Labquality since 1990. Biochemist Hanna Heikkilä will take over Anna-Riitta's EQA rounds.Read now the new customer reference
Peili Vision has chosen Labquality as the partner for a clinical study to assess the performance and safety of their browser-based, game-like medical software.Subscribe to our newsletter
Subscribe to hear the latest news in the industry and keep track of what's happening behind the scenes.