Skip to content
menu-icon-lq
close-icon-lq
QMS

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-frame-green (5)

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.
labquality-frame-blue (1)

QMS Gap Analysis

Examples of QMS Gap Analysis we have been working on:

MDD versus MDR
IVDD versus IVDR
ISO 13485 versus IVDR/MDR
ISO 13485 and ISO 9001 standard version changes
ISO 13485 versus US FDA 21 CFR Title 820 (QSR)
ISO 13485 versus MDSAP
ISO 14971 standard version changes
 
Meeri Säily

Contact us for more information

user
Meeri Säily
Sales Manager
contact-email
meeri.saily@labquality.com

Leave a contact request

Related Services

Quality Management System ISO 13485
QMS
Auditing services

Quality Management System ISO 13485

Labquality provides medical device manufacturers help with setting up quality management systems (QMS).

Read more
US FDA 21 CFR Title 820 (QSR)
QMS

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.

Read more

Latest news

03/27/2023

Labquality to expand clinical trial services to pharmaceuticals and biotech

Labquality corporation acquires Clinical Consulting corporation, a Polish company that specializes in clinical trial services for pharmaceuticals, biotech, and medical device companies.
Read more
03/15/2023

Registration for new pilot rounds now open

Register now for our planned pilot rounds free of charge.
Read more
03/13/2023

Welcome to our new website!

Our new and modern website offers a user-friendly experience for our customers.
Read more
03/03/2023

Extension of the MDR transition period – do not stop working towards the certification!

The European Parliament recently approved the extension of the MDR transition period. What does this mean for medical device manufacturers?
Read more
03/02/2023

Data management in clinical investigations – Part 3: Data traceability

Data traceability is a foundational principle for clinical investigations aiming to demonstrate the performance and safety of medical devices.
Read more

Subscribe to our newsletter

Subscribe to hear the latest news in the industry and keep track of what's happening behind the scenes.