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Need Compliance?

Quality Systems Consulting Services provides Regulatory Compliance Consulting, Operational Excellence programs, Validation support, Remediation Solutions, and Staff Augmentation to medical device and pharmaceutical companies.

Our goal is to provide you with REVENUE NEUTRAL COMPLIANCE: delivering Regulatory Compliance while identifying and implementing opportunities for effectiveness and efficiency

PROACTIVELY ADDRESS
QUALITY SYSTEM OPPORTUNITIES

The internal and external costs of non-compliance resulting from the Food and Drug Administration regulatory actions or Notified Body findings can be significant. Proactively addressing any non-compliance or quality systems issues BEFORE they become a problem will help your business build brand strength and produce a higher quality product.

Stay Ahead
of the Curve

Effective and Efficient Compliance Strategies

Invest in
Quality Systems

Quality Systems Consulting Services

Three Easy Steps to Solve Your Problem

A QSCS Consultant’s job is to help your company succeed. We have the experience and knowledge to help your business deal with quality and compliance issues that may arise.

The steps to stress-free compliance are:

Call us to discuss your needs.
Together we will develop the strategy to solve your problem
We provide the consultants that will help your company succeed.

Let Your Compliance Solution Pay for Itself

Quality System Consulting Services can help you develop, improve, remediate, and optimize all of your global quality system and regulatory requirements. It is our goal to provide you with REVENUE NEUTRAL compliance.

insulet

I can’t say enough about QSCS.  While we initially engaged their services to manage several projects focused on upgrading our quality system, their professionalism and customer service made them an easy choice to help support us project management and completion of all requisite validation activities for the startup of a $200MM+ manufacturing facility. Their team worked seamlessly with all levels and functions of our organization successfully managing and completing 100s of validations… 

Kim Ruzek
Vice President, Quality Systems and Operations
Insulet Corporation
angiodynamics

We hired Quality System Consulting Services to help support Operational Excellence activities within one of our manufacturing facilities. They mentioned their goal was to be “revenue neutral.”  Well, they far surpassed that, as we actually came out positive on this engagement! 

We again solicited the services of QSCS to help us support our EUMDR compliance plan while at the same time helping us move nine separate production lines into a new manufacturing facility, including the handling of all of the project management and validation activities.  We are now EUMDR compliant, and our equipment move and validations were done successfully and on time.

Warren Nighan
Senior Vice President, Quality and Regulatory Affairs
ICU Medical
Angiodynamics Inc.
hospira logo

We enlisted the services of QSCS to work with us to support the development and implementation of a comprehensive remediation plan. In a short period of time, they were able to assemble a very professional and highly qualified team covering all areas of our global quality system…

Joseph Sener
Vice President Quality, Device Engineering
ICU Medical
Hospira Corporation

Top Notch Consultants
for Businesses Large and Small

Our consultants and partners have experience and skills representing a “who’s who” within the Medical Device and Pharmaceutical Industry. They are industry leaders that come from different levels (Vice Presidents, Directors, Managers and Engineers) and from different functions (Quality Assurance, Regulatory Affairs, Research and Development, and Operations). They have worked in small, start-up enterprises up to multi-billion dollar, multi-national organizations.

They have lead or provided guidance in remediating FDA a nd Notified Body enforcement including Consent Decrees, Warning Letters, Recalls, Post-Market Surveillance, MDRs, and problem CAPAs.

Just a few of the companies who have trusted us with the compliance needs:

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Clear guidance by utilizing centuries of FDA and INDUSTRY EXPERIENCE along with a passion and history of applying OPERATIONAL EXCELLENCE to deliver our unique VALUE PROPOSITION: REVENUE NEUTRAL COMPLIANCE

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