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

  • Meetings with FDA and other Authorities

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

  • Establishment listing, MDALL, FURLS, etc 

  • Covid-19 US EUA and Canada Interim Order

MDR/IVDR and UKCA Approvals

Regulatory strategy to maintain compliance in Europe 

  • EU-MDR/IVDR CE Mark submissions

  • Qualified PRRC (Person Responsible for Regulatory Compliance)

  • EU-MDR/IVDR gap analysis, Documentation update, QMS update

  • UKCA mark

QUALITY MANAGEMENT SYSTEM

Operational excellence and cost saving

  • Establishing ISO 13485:2016, FDA 21 CFR 820, MDSAP

  • ISO 14971, IEC 62304, IEC 60601 compliance

  • 13485:2016 audits, internal and supplier audits

  • Change management

  • Process validation (e.g. cleanroom, sterilization)

  • Training on Regulatory and QMS requirements

Asia, Middle East & Latin America Liaison

Expand your business

  • Global regulatory strategy

  • Prototyping and manufacturing in Taiwan

  • Distributor qualification and submission management

  • Guidance on local requirements and regulatory culture

  • Guidance on local authority audits (KFDA, InMetro...)

RECENT PROJECTS

Endoscopy

Global regulatory strategy upon acquisition

Quality Management System transfer

Radiotherapy

Device classification

Regulatory strategy for Canada & the US

Investigational Testing documentation

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

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