Services: Medical Device

Medical Device | Combination Product | Pharmaceutical | Dietary Supplements

QIS, Inc. provides support with a multi-disciplinary team widely experienced in all facets of the medical device industry.  We facilitate knowing when and how to harmonize science, compliance, training and business goals to exactly offer value-added solutions for regulatory and quality needs.  Solutions are customized to the stage and size of the company to provide essential foundations for product realization and market success. 

QIS, Inc. offers a wide range of training that is tailored to the audience from executive management to engineers and is always customized to satisfy your specific learning needs.   

Quality Assurance

Technical Support & Review

QSR-GMP GAP Analysis

Design and development planning

Due Diligence Audits

Design verification and validation

Mock Inspection Audits

Engineering Reports

DHF and DMR Gap Analysis

DHF and DMR support

Remediation Support Services

Design and Manufacturing records

SOP development and compliance support

Process Validation

QSR subsystems compliance support

Quality Control records

ISO 13485 compliance support

Risk Management

In-Vitro Diagnostic compliance support


Supplier Vendor Programs

QSR Overview


Design Controls

Training Program Implementation support

The Regulatory Submission Process and types of 510(k)’s

Quality Control Implementation support

How to classify your product

Regulatory Affairs

How does a Small Company get started with QSR compliance


What documents are needed in a 510(k) submission


Good Documentation and Recordkeeping Practices


Hosting an FDA Inspection

Design Dossiers/Technical File

When to submit a 510(k) for a new or changed product.

FD-483 and Warning Letter remediation activities

User Fees and Establishment Registration


Risk Management


Most common 510(k) delays and how to prevent them


Most Common 483 and Warning Letter Trends For This Year

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