Examples of projects we supported

CE Marking under the EU-MDR for a substance based Medical Device

Hyaluronic Acid eye drops are considered medical devices. The new EU regulation, created a new classification Rule, Rule 21 specifically for this type of devices.

Visual Field exam (Digital Ophthalmology)

The ophthalmology world is going through a VR/AR revolution.

We worked with Medical Device manufacturers to help them bring these devices to market and increase access to eye care.

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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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Laser eye treatment for Age-related Macular Degenerative disease (AMD)

We helped this manufacturer get an MDSAP certification in Canada, Australia and the US.

Following which we also submitted an MDL (Medical Device Licence) to support their commercialization plans in Canada and many other regions in the world.

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Ovulation Test with mobile App

At home testing is further enhanced with Software applications where the user can track their personal data and get very frequent insights in their hormonal levels.

We were able to support one of the most innovative companies to get their devices to the US.

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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Breast cancer treatment support

We helped the QMS establishment and licence approval for an innovative accessory intended for use during Radiotherapy sessions by patients with large breasts.

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Fluorescence imaging endoscopy

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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