Case Studies

Navigating Regulatory Pathways for a Radiotherapy Support Accessory

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Fast-Track Regulatory Approval for a Visual Acuity App in Canada

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Navigating Global Regulatory Complexity for Hyaluronic Acid Eye Drops

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Streamlining MDSAP Certification — Example of a Laser Therapy Ophthalmic Device

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Supporting Dual Regulatory Pathways for Continuous Hormone Monitoring IVDs

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VR-Based Medical Device Case Study

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Scaling 3D Printed Medical Devices for Global Health Impact

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EU-MDR RESULTS WE'VE HELPED CREATE

100%

Complete EU-MDR Class IIb CE Mark submission (current pass rate is 50%)

Questions in the first review round (20 deficiencies is generally regarded as excellent)

Zero

Major non-conformances during EU-MDR QMS upgrade audit combined with MDSAP recertification

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PROCESS RESULTS WE'VE HELPED CREATE

15%

Labelling and translation cost reduction through regulatory streamlining of international business

100%

Clearing of 4- and 3-year technical change assessment backlogs in 6 and 4 months, respectively

300%

Autoclave use time reduction through moist heat sterilization process improvement

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3 months

(instead of 12)

to full implementation of PQM (Product Quality Management) system for non-conformance handling

3 months

(instead of 12)

to full regulatory remediation, including re-registrations with local authorities and labelling updates

4 months

(instead of 18)

to complete

Quality System integration

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BOTTOM LINE RESULTS WE'VE HELPED CREATE

100%

Compliance strategy for a production site relocation from Europe to Thailand

25%

Market share growth in China for a professional haircare brand

Zero

interruption to business

through global regulatory strategy for a class III animal tissue-based implantable change in chemical sterilant and critical sterilization equipment

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CONTACT US

At QARALOGIC we provide exquisite Regulatory and Quality advisory services for medical device companies. We are certified Regulatory and Quality professionals who are results driven and passionate about bringing the best technologies to patients.

BSI lead auditor certification ISO 13485:2016