Ing. Curtis Sizer

LyfMedics is a consultancy that cares about quality products and the well being of people.

Regulatory Affairs certificate, Medical Devices and Pharma. QA, QC, development, Design Transfer, Auditing • Quality of products, but not just a final product, but the Process to quality products. • Remediation of devices (Regulatory, Quality and Process Validation) from some of the worlds largest corporations. working with Notified Bodies, focusing on regulatory entities i.e. • EUMDR(DDR) • FDA

Evaluate and perform Gap analysis for the Testing coverage and Test Methods for an IVD system. Identifying and fulfilling User Needs through System Requirement/Sub-System Requirements. Developing DOE and Pre-Validation activities to avoid Final Validation Deviations/Failures. Preparing all the data from technical requirements and completion reports together to develop the Final Validation Test Protocols for final reports.

CAPA design change evaluation for GAP analysis used on manufacturing and assembly processes, ensuring validations through, IQ, OQ, PQ, V&V, FMEA procedures and risk analysis (ISO 14971) assisting with medical device GMP. Developing and maintaining ISO 13485 compliance for product sustaining procedures. Completing a new digital DMR file system for maintaining a DHF and GMP practice. Finished an extensive gap analysis for remediation and successfully passing the FDA Re- Inspection!

Kicked-off and introduced effective execution plan of action for progression of projects that will meet all regulatory requirements for product approvals. The projects were brought in accordance with domestic and international regulations and standards. Developed project timelines and budgets, ensuring the successful evolution with allocated resources. Reported directly to management for each project while maintaining coordination with Quality, R&D, manufacturing and Regulatory departments.

Design History File (DHF) reconstruction for combination products. Document and categorization findings to develop recommend remediation strategies for compliance of gaps which complies with ISO 13485, 21 CFR Part 820 part 20/30.

PFDs, P&IDs Line Sizing. Tube and shell heat exchanger design with “HTRI” data, modeled and tested completed in “Compress”. Engineering calculations for PSVs, flare systems, KODs. Updating specification sheets for process equipment, separation columns, pumps, instrumentation valves, simulation using PRO-max data. Experience with; ASME B31.4, B31.8, DOT 195, DOT 192, API, NACE. EPA regulations for Organic liquids and VOC for rail loading sites, pipe and storage facilities with containment.

Consultant for product outsourcing, engineering / business strategy. Selection of local and global key suppliers for future business. Coordination of production, assembly and order fulfillment (Ramp up). Planning and creation of a clean Bill of Materials and all documents from prototype. Coordination of internal resources, in cooperation with the Complete CM transfer of complex polyamide parts for industrial battery.

Complete manufacturing line design/support for production systems with reaction polyurethane machines (RIM). The technical, commercial and contractual clarification for practical solutions. Cost accounting and pricing for equipment and design. Mezzanine, electronics and robotic design were completed in house. Complete factory layout and position of all sub-components, i.e. vessels, polyurethane lines, cables and robots were given final commissioning.

Create FMEA. Review product spec's, conceptual designs, manufacturing concepts(GMP). FMEA procedures. Maintaining ISO 13485 21 CFR 820/821 compliance for all products in the USA & offshore. Control a detailed DHF at all times. Design all parts & molding tools/processes, machined components. Always Improve SOP's. Facilitate & execute test/build protocols. Develop vendor contacts, approve prototypes and raw materials. Continuous improvement on products.

Various positions from COBE Laboratories, Reebok, Maxtor Development, BMW Rohde & Schwarz. 3-4 years of Medical experience, +20 years of R&D to Production. Materials Guru for medical devices to military field radios. Professional Knowledge of ISO 13485 21 CFR 820/821 and ISO 14971.

Mechanical Engineering

Mechanical engineering