Quality Management Systems

Quality Management Systems for the Medical Device Industry

A Quality Management System (QMS) is a necessary supporting structure of a company. It secures consistent company operations, which are compliant with applicable standards and regulations. Implementing a QMS requires set processes and forms but also a culture of performing operations in a planned manner and improving them to perfection over time. Depending on your company type and structure, its products, services and electronic tools used, the quality management system will differ.

A quality management system is often mandatory, but it should not be limited to that. A QMS can offer added value and benefits to companies through a systematic approach. We have expertise in several quality management system standards including but not limited to ISO 13485, US FDA QSR, ISO 9001, ISO 15189, ISO 17025 and ISO 20387. We also have experience with a wide array of different product types (including IVDs, implantable devices, and software...).

Electronic Quality Management Systems

There are multiple alternative for Electronic Quality Management Systems (eQMS) solutions. Overall, it is recommended to use an electronic QMS instead of a paper-based solution. Typical QMS functionalities are

document control - eQMS takes care of
- automatic IDs
- duplicate ID prevention
- revision control
- electronic signatures
- audit trail logs
- backups
training functionalities
change control,
complaint handling,
CAPAs.
Design control
Risk management
Tracking changes with author/time stamps

See an example of an eQMS: Scilife

We can support you in the following:

Internal audit of your QMS
GAP analysis of your QMS according to any requirements (FDA QSR, MDSAP, MDR, IVDR, ISO 13485, ISO 9001...)
Selecting the right eQMS for you
Modifications to your QMS due to eQMS implementation
Planning and implementing a new QMS
Switching from paper-based QMS to electronic

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Quality Management System ISO 13485

Setting up quality management systems (QMS) for medical device manufacturers.

US FDA 21 CFR Title 820 (QSR)

We know quality systems, including the USA Food and Drug Administration Quality System Regulation, QSR, 21 CFR Title 820.

QMS Improvement and Gap Analysis

Improvement of medical device manufacturer’s quality management system (QMS) and GAP analysis.

Success in quality management

Quality management systems are dynamic and require updating. Minor updates occur frequently with the principles of continuous improvement, but larger updates often occur when entering new markets, and in case of regulation or standard updates, product portfolio updates, new business areas, or company mergers.

We evaluate the need for changes and perform documented GAP analyses against any set of requirements, for QMS or medical device technical documentation.

How can we help?

We maintain and improve your 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:

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

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Quality Management Systems (QMS)