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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