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Healthcare Software Quality Assurance

Our Software Quality Assurance (SQA) professionals work with you to ensure medical devices are safe, effective, and appropriate for their intended use.
 
We collaborate with engineers, quality managers, regulatory personnel, manufacturing personnel, clinical staff, research staff, and development staff, to ensure software surpasses industry standards.

"Before we start talking about our support, can we have a minute please!"

Breaking a little bit of the 4th wall here for our audience, we need to align in terminology and what we mean. This is super important!

We define Computer Software Validation (CSV) as the application and validation of computer-based software.

Software Quality Assurance on the other hand is specifically focused on internal quality control procedures and deliverables that developers must put into place before release of software or firmware.

The term SaMD refers to something much more specific - when a piece of software functions as an actual medical device.

How you approach development, validation and risk controls for Software/firmware, applications and SaMD are different, we can go into this in more detail when we speak. But it is important that we make this distinction. 

VR Goggles

Medical Device Validation to IEC 62304

Are you developing a medical device that uses software, or developing SaMD (Software as a Medical Device?

 

If you are, then let us support you in ensuring the development of a safe and effective device, that meets regulatory requirements.

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Computer System Validation to GAMP 5

Do your GxP computer-based systems operate as intended (with documents to prove it) and meet regulatory requirements?

Regulatory agencies around the world require that companies perform documented validation to prove that their software or computerized system does exactly what it is designed to do in a consistent and reproducible manner throughout its lifetime.
 
We can help.

Support

We work with you across all components of SQA creation to day-day administration. 

Data Integrity

Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.

Risk Management

Assessing system risks and providing recommendations for a risk-based approach to validation activities.

Software V&V

Providing support with validation lifecycle activities to prove that your system works in its intended environment​.

Gap Analysis

Conducting  gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.

Cloud Validation

(IaaS, PaaS, SaaS)

Validation Support of cloud-based systems,  ensuring compliance to International regulations.

21 CFR Part 11 Compliance

Provide guidance in ensuring your electronic records and signatures are considered to be trustworthy and equivalent to paper records.

Lifecycle Documentation

We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.

Configuration Management

Working with you to Define strategies for handling changes systematically so that a system maintains its integrity over time.

Software Supplier audits

Carrying out audits on vendors of software and systems and providing documentation to support your validation strategy and demonstrate regulatory compliance. 

Validation Strategy & Management

Supporting you in  the development of compliant approach's to your computer system validation.

Spreadsheet Validation

Verifying the reliability of your spreadsheet and its output for its intended use.

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Let Us Help You 

We are Medical Device Consultants, We are Medical Device Contractors, and your one-stop-shop for all things quality.