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INDUSTRY

SEGMENTS

SERVED

Capital equipment

Clinical laboratory

Diagnostic apparatuses

Orthopedics

Software as a medical device (SaMD)

Surgical instruments

CORE EXPERTISE

Quality System Implementation & Compliance

New Product Development & Design Controls
Design History File Implementation & Remediation

Risk Management

Software Life Cycle Management

Human Factors Analysis & Usability Assessments

Manufacturing Process & Supplier Development

Current Good Manufacturing Practices (cGMP)

Failure Analysis, Corrective & Preventive Action (CAPA)

Post-Market Surveillance

Our Services

QUALITY
MANAGEMENT
SYSTEMS

    Whether you're in concept clinicals or making the final push to commercialization, Quality Devices will help your firm establish and implement a QMS that is specific to the immediate needs of your company. 

    Our QMS package is designed to comply with 21 CFR 820, ISO 13485:2016, ISO 14971:2012, IEC 62304:2015, and IEC 62366:2015 and includes forms, templates, and additional guidance.

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Quality Management Systems

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DESIGN
ASSURANCE
ENGINEERING

    Quality Devices will serve as an extension to your organization to meet the quality assurance needs for your project. 

    Our team will help assemble your product's design history file in preparation for regulatory submissions. We help translate customer feedback into formalized user needs, generate product risk management files and engineering requirements, and help assess conformance to applicable standards.

Design Assurance Engineering

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QUALITY
TRAINING
& COACHING

    We provide personalized instruction to individuals new to quality management systems and medical device design controls. Our consultants will coach individuals on core quality system job processes and are on call to answer any outstanding questions.

    Our team also provides formalized group training events to get your team up to speed on the topics of design controls, risk management, usability engineering, and quality management systems.

Quality Training & Coaching

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QUALITY
AUDITING &
DILIGENCE

    We are a team of ASQ certified and ISO 13485 lead auditors with extensive experience performing quality system audits and preparing for regulatory submissions.

    Our team conducts inspection readiness, internal audits, supplier audits, mock FDA and MDSAP inspections, and due diligence audits to ensure that the quality system and associated records are compliant with quality and regulatory requirements and applicable standards.

Quality Auditing & Diligence

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