Steven Skerritt
President
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QA - Regulatory
ISO 9001/13485 Assessment/ Development Quality Management Systems Internal & Supplier Auditing Regulatory Submissions FDA Mock Audits CAPA Planning & Implementation Change Control System Management ERP Implementation & Control
Validation & Engineering
Cleanroom and Sterile Packaging ImplementationValidation/ Equipment Qualifications Special Process Validation Plant Expansions/ Cleanrooms Quality, Manufacturing & CAD Engineering CMM Programming Measurement Systems Project & Supply Chain Management
Lean-Six SIGMA
Lean Process Flow Analysis and Improvement5S Training and ImplementationSetup Reduction (SMED) Improved Capability (SPC) System Control & Monitoring (VSM) Belt Training (DMAIC) Process Flow Analysis
Due Diligence
Support Acquisition / Merger Due Diligence Activities Quality Management System: In-Depth Review and Gap Analysis Regulatory System: Labeling, Complaint and Postmarket Surveillance Product Development: Design History Files, 510(k) Submissions, Pre-Market Approvals Supply Chain: Review and Evaluation
Don’t Hesitate, Contact us today.
ABOUT SIGMA SOS CONSULTANTS
Comprehensive Solutions from Seasoned Experts.
Dedicated Service to the Medical Device Supplier.
Over our past 25 years of experience in Medical Device Industry and having worked in many different roles in manufacturing engineering, quality engineering, validation engineering, product development engineering, master black belts, regulatory and business owners we can speak of one certainty "There will be change". SIGMA-SOS Consulting provides you a seasoned expert for those important business changes and allows your current staff to stay focused on the number one priority of on-time delivery of quality products to your customer. Sigma (SOS) provides a service in 3 general areas including Validation-Engineering, Supplier Development, and QA-Regulatory support. Our staff members share three important traits that set them apart from the others first, we have a passion for serving, second we are respected experts within our industry and finally we know medical device and are able to adapt quickly into your environment. Our goal is to become more than just a service but your valued partner for success.
OUR PROCESS
A Process for
Your Success
Stakeholder Analysis
We will conduct a stakeholder analysis and identify priority issues.
Consultation Plan
We will prepare and present a detailed consultation plan addressing all project goals.
Analysis & Work Plan
Encorporate stakeholder feedback and synthesize findings.
Recomendations
We will prepare and present detailed recommendations based on our findings.
