Our Services

Services

Quality Management Systems (QMS)
& Medical Device Compliance

At PQC, we know what it takes for MedTech firms to meet strict regulatory requirements for validation, auditing, and controls. Our team works with our clients to determine the right type of QMS that allows them to meet their product development milestones while maintaining financial goals.

We offer supplier and internal audit services to help our clients meet regulatory compliance, in addition risk planning and mitigation. Once we begin a QMS plan, we provide ongoing maintenance and quality control to ensure all necessary production controls, certifications, and systems monitoring are in accordance with industry standards and regulatory practices.

Our services facilitate continuous improvement in standards and systems, strengthening our clients’ device development, manufacturing, and distribution processes.

QMS Services

  • Device Compliance Essentials for Startups
  • Remediation:
    • QMS
    • Product
  • Manufacturing Process & Design Improvements
  • FDA QSR & ISO 13485 Compliance
  • KPI Performance Analysis
  • First in Human
  • FDB Certification & Audits
  • Medical Device QMS Implementation
  • Outsourced Medical Device Quality Control
  • Quality Systems Training
  • Quality Management Systems Enhancements
  • Additional compliance development: MDR, CMDR, GMP, GLP

eQMS Solutions

Electronic Quality Management Systems (eQMS) solutions provide a sustainable alternative to standard paper-based QMS solutions through more efficient document control, compliant handling, CAPAs, design control, and risk mitigation. Our team will work with clients looking for the right eQMS solution to help reduce costs, enhance collaboration, and improve efficiency. These solutions also streamline the auditing and compliance process, and they are highly scalable for whatever our clients need. If you have questions about eQMS solutions, contact us now.

Additional Services

Passaglia Quality Consulting:
Quality that Delivers Peace of Mind

At Passaglia Quality Consulting (PQC), we help medical device companies achieve peace of mind by building team competency, streamlining quality systems, and ensuring consistent product quality. Our mission is to protect your bottom line by reducing quality errors, improving operational efficiency, and ensuring full regulatory compliance so you can confidently focus on innovation and growth.

With deep expertise across quality, design, and operations, PQC provides practical, tailored solutions that turn quality into your competitive advantage.

Quality Assurance &
Regulatory Compliance

We simplify the complex. PQC helps you navigate FDA regulations and international standards with confidence. Our team delivers detailed audits, proactive risk assessments, and strategic compliance planning, ensuring your systems are both inspection-ready and business-ready.

Design &
Development Consulting

From concept to commercialization, we guide your team through robust design controls, innovative documentation strategies, and efficient design verification and validation. The result? Devices that are safe, effective, and fully aligned with regulatory expectations.

Process Optimization & Continuous Improvement

We identify inefficiencies, reduce rework, and implement scalable, lean processes that drive consistent quality and reduce operational costs. Our continuous improvement strategies directly support your bottom line through fewer errors and faster throughput.

Project Management & Integration

PQC integrates seamlessly into your operations, managing projects with precision and discipline. We ensure timelines, budgets, and quality expectations are all met, without adding stress or complexity to your team.

Training & Development

Competency builds confidence. Our customized training programs empower your team to own quality and compliance. Whether it’s QMS fundamentals, regulatory requirements, or best practices in design and operations, we make sure your people are your strongest asset.

First in Human

Product milestones can be daunting. If you have a First in Human milestone, turn to PQC. Our team works with clients during clinical phasing to meet product development needs. Our streamlined approach will ensure quality standards are met, along with regulatory compliance.