YOU ADVANCE MEDICAL CARE.

WE PROVE IT.

MedTech and Digital Health
Regulatory Affairs and Quality Assurance

From early product development stages, to registration dossier building, to ultra-efficient regulatory strategies, we are ready to tackle your challenges and put you on the path to success.

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SERVICES

Our strategic services meet the needs of all types and sizes of Medical Device manufacturer clients -

from small startups to large firms - and deliver lasting changes with measurable growth. 

 

MARKET APPROVAL/CLEARANCE

Submissions to the US, Canada, Europe and Australia

  • Q-Submissions/Pre-submissions

  • Regulatory submissions: US FDA 510(k), Health Canada MDEL, TGA, CE Mark, UKCA

  • Establishment listing, MDALL, FURLS, etc 

  • Meetings with FDA and other Authorities

EU-MDR and UKCA Approvals

Regulatory strategy to maintain compliance in Europe 

  • EU-MDR CE Mark submission

  • EU-MDR gap analysis

  • Documentation update

  • Quality Management System update

  • UKCA mark

  • Qualified PRRC (Person Responsible for Regulatory Compliance)

QUALITY MANAGEMENT SYSTEM

Operational excellence and cost saving

  • Establishing ISO 13485:2016

  • FDA 21 CFR 820

  • MDSAP

  • 13485:2016 audits

  • Change management and controls

  • Process validation (e.g. steam sterilization)

  • Training on Regulatory and QMS requirements

Asia MARKET ACCESS

Expand your business

  • Asia regulatory strategy

  • Prototyping and manufacturing in Taiwan

  • Distributor qualification 

  • Regulatory submission management

  • Local regulatory requirements

RECENT PROJECTS

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Europe+RoW

Endoscopy

Global regulatory strategy upon acquisition

Quality Management System transfer

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Health Canada

Radiotherapy

Device classification

Regulatory strategy for Canada & the US

Investigational Testing documentation

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Covid-19 EUA

Oxygen therapy

EUA submission preparation

Meetings with the FDA

21 CFR 820 requirements

TESTIMONIALS DO THE TALKING

It was a great presentation that you give for us, and we really enjoy it. Thank you so much for sharing valuable experience with us. We really learnt a lot from you.

Wendy Ke, Sr. Engineer at QualTech Consulting

OUR PARTNERS

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PROFESSIONAL ACCREDITATION

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PROFESSIONAL MEMBERSHIPS

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