MedLark LLC is a Quality and Regulatory consulting firm dedicated to serving the healthcare, medical device, pharmaceutical, and biotech industries. We strive to provide you with increased and personalized service suited to your unique product or project. Read ahead for our services offered.
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Services
Third Party Audits and Inspection Readiness
-Quality System Audits (ISO 13485, 21 CFR, MDSAP, ISO 9001, MDD, EU MDR etc.)
-Inspection Readiness Audits
-Due Diligence, Gap Identification, Integration Preparation
-Audit Front Room / Back Room Management for Regulatory or Health Authority Audits
Quality System Maintenance, Development, or Improvement
-Acquisition Integration
-Quality Planning and QMS Project Management
-SOP Development or Documentation Reviews
-Standard / Regulation Assessments
-Quality System Remediation Management
-CAPA, Nonconformance, Audit Responses
Training
-Instructor-Led or Read and Comprehend Training
-Quality System Regulations
-Internal Auditing
-Inspection Readiness
-Audit Management
-Root Cause Analysis
-Audit Response
Regulatory Submissions
-Regulatory Strategy Development
-Technical Documentation Review
-Submission Writing / Review
Resham Ramsay, CEO MedLark LLC
Resham is recognized for her capabilities in strategic planning and seeing the smaller pieces within a widespread initiative. Her focus is on ensuring that cross-functional processes are carried out in a safe, effective, and compliant manner that is easily understood by involved parties. Her background carries through to other industries in which in-depth planning, regulatory compliance, and stakeholder engagement are beneficial, such as higher education and community living. Resham maintains certifications in ISO auditing and Regulatory Affairs.
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Medical Device Consultant | Regulatory & Quality System 