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Exceed Your Goals Through Comprehensive and Precise Systems Development

Quality Assurance is an essential aspect of any company working in the fields of medical device development, medical device manufacturing, and biotechnology. Through strategic consulting, QMS systems development and implementation, external and internal auditing and quality engineering assistance offered by Paradigm Consulting Services, your company can focus on growth while saving money on staff costs. Our staff has more than 30 years of experience, and is focused on helping you succeed.

PCS has successfully developed and led complete QMS development projects. Subsequent to QMS development, we also work with clients as the liason during US FDA and State of California DHS site audits.

PCS has also successfully completed full ISO 9000:2015 transition projects on behalf of clients.

Work with a Team That Supports Your Goals

We provide your organization with an outside perspective that allows you to identify potential problems that could cost you dearly. This additional expertise helps you to meet your objectives while complying with state and federal regulations. Our services include both consulting and development assistance in Quality Management Systems and related areas. 


FDA

QSR (GMP/cGMP) Compliance Audits | Design Control | Procedural Development | Compliant Investigation | Quality Systems Development | Remediation and Implementation | Facilitation Assistance | Training

ISO

ISO 9000-2008 | Pre-assessment Audits | Compliance Assistance | Procedural Development | Transition from ISO 9000:2008 to the new 9000:2015 version |Consulting and Implementation Services for ISO 9000:2015 | ISO-13485:2016 | Assistance with the Selection of an Appropriate Registrar | Training

Quality Assurance

Strategic Consulting | Quality Policy | Quality Manual | Internal Auditing | Document Control | Corrective Action | Material Review Board

Supplier Quality

Supplier Audits | Selection and Qualification | Rating Programs | Partnership Programs

Quality Engineering

Statistical Process Control | Qualification Test Methods | Failure Analysis Methodology | Root-Cause Analysis | Sampling | FMEA/FMECA | DOE