QMS Implementation: Building a compliant Quality Management System from the ground up, tailored to your company's size and needs.

Existing QMS Consulting: Reviewing and optimizing your current QMS to improve efficiency and ensure compliance with standards like 21 CFR Part 820 and ISO 13485.

Process Optimization & Improvement: Analyzing and streamlining your workflows to reduce waste, increase efficiency, and enhance overall operational effectiveness.

Internal & Supplier Auditing: Performing comprehensive internal audits to prepare for regulatory inspections and conducting supplier audits to ensure compliance throughout your supply chain.

SOP Development: Creating, revising, and implementing a full suite of Standard Operating Procedures (SOPs) and other controlled documents.

CAPA & Nonconformance: Establishing and managing systems for Corrective and Preventive Actions (CAPA) and nonconformance to address issues effectively.

Pre-Market Submissions: Assisting with the preparation and submission of FDA 510(k) and De Novo applications to secure market clearance.

Post-Market Surveillance & Vigilance: Developing and implementing post-market surveillance plans and reporting systems to comply with regulatory requirements.

Regulatory Strategy: Guiding your team on the most efficient and compliant regulatory pathway for your products in the U.S. and international markets.

Design Control: Establishing a robust Design Control process in compliance with 21 CFR Part 820 to ensure your products are safe and effective.

Risk Management: Developing and maintaining risk management files in accordance with ISO 14971 to identify and mitigate product risks.

General Consulting: Providing expert guidance on a per-project or retainer basis for various quality and regulatory challenges.

Interdisciplinary Connections: Leveraging a professional network to connect you with trusted experts in other fields, such as cybersecurity, electrical engineering, or IT, as needed.