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Our Services

LEXQARA was established to support medical device manufacturers by providing comprehensive QA/RA and clinical services in consulting, auditing, training, regulatory documentation and QMS implementation.

Expert in Medical Device Compliance

LEXQARA has developed a range of solutions to support medical device manufacturers with their quality and regulatory concerns. Our expertise ensures you achieve your business objectives while maintaining compliance with all applicable requirements.

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clinical-activites-v2

Clinical
Activities CEP, CER and SSCP

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audit-v2

Audit and
Inspection Support NB audit, CA or FDA inspection

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quality-audit

Post-Market
Activities PMS plan & report, PSUR, Summary Reports PMCF plan and PMCF Evaluation Report

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implementation

Quality Management
System Audit Internal, supplier, distributor audits (MDR, QSR, MDSAP)

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r-submissions

Regulatory Submissions Technical Documentation, Notified Body Opinion, 510(k) gap analysis and compilation

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design

Quality
Management
System Creation
and Implementation ISO 13485, QSR

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p-m-activities

Design Control Device History File, Risk Management File

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training-v2

Trainings MDR, ISO13485, risk management, FDA regulatory framework, 510(k), internal audit, clinical evaluation, PMS, PMCF

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r-strategy

Regulatory Strategy Classification determination, Regulatory pathway, Search report

Have questions?

You will get an answer within 24h.

LEXQARA supports medical device manufacturers with quality and regulatory services through consulting, audit, training and regulatory documentation.

Contact

+33(0)6 87 45 88 07
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