Annalyn L.

I help companies in the Medical Device, Pharmaceutical, Logistics, and Supply Chain industry improve audit readiness, streamline document workflows, improve efficiency through process mapping and guided DMAIC projects, and establish integrated management systems (ISO, GMP, GDP) in compliance with regulatory bodies such as FDA, Medical Device Regulation (EU) 2017/745 (MDR) and Health Sciences Authority in Singapore (HSA) Previous clients improved induction/ on-boarding training by 50%, planning efficiency by 30%, and benefited from significant amount of cost avoidance. How I Can Help • Process Optimization • Process mapping (SIPOC, Value Stream Mapping) • DMAIC and Lean Six Sigma projects • Efficiency and cost-reduction initiatives • Regulatory Affairs & Compliance • GMP and GDP compliance • Medical Device regulatory support • Gap assessments and remediation plans • Audit preparation and internal audits • Integrated Management Systems (IMS) • Implementation of ISO 9001, ISO 14001, and ISO 45001 • Development of Quality Manuals, SOPs, and policies • Risk management and continuous improvement frameworks • Technical Documentation • SOPs and Work Instructions • Quality and compliance manuals • Training and onboarding materials • Document control and workflow optimization Proven Results ✅ 50% improvement in induction and onboarding training efficiency through structured documentation. ✅ 30% increase in planning efficiency via process optimization initiatives. ✅ €27.9K annual cost avoidance from a Lean Six Sigma Green Belt project. ✅ Six consecutive years of successful IMS certification audits (ISO 9001, ISO 14001, ISO 45001) with zero major non-conformities. ✅ Successful GDP certification for Medical Devices, enabling the acquisition of the company’s first medical device customer. Professional Certifications ✔️ Six Sigma Green Belt (Certified) ✔️ Medical Device Auditor (Certified) ✔️ ISO 9001 Auditor ✔️ ISO 45001 Auditor Why Clients Choose Me ✔️ Strategic, results-driven approach to compliance and efficiency ✔️ Deep understanding of regulated industries ✔️ Ability to translate regulations into practical business processes ✔️ Proven track record of successful audits and certifications ✔️ Clear and compliant technical documentation