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Services

Quality Management System (QMS Creation)

Quality Management System (QMS Creation)

Quality Management System (QMS Creation)

Remediation Services

Quality Management System (QMS Creation)

Quality Management System (QMS Creation)

Quality System (Qms) Upgrading

Quality Management System (QMS Creation)

Quality System (Qms) Upgrading

QMS/QSR - Gap Analysis

QMS and QSR - Auditing (Internal & External)

Quality System (Qms) Upgrading

QMS and QSR - Auditing (Internal & External)

QMS and QSR - Auditing (Internal & External)

QMS and QSR - Auditing (Internal & External)

Risk Management System Implementation

QMS and QSR - Auditing (Internal & External)

QMS and QSR - Auditing (Internal & External)

Software Validation

Technical documentation readiness

510k Readiness & Submission

510k Readiness & Submission

Technical documentation readiness

510k Readiness & Submission

Technical documentation readiness

Technical documentation readiness

Technical documentation readiness

Quality Management System (QMS) Creation

ISO 13485:2016

EU MDR 2017/745

ISO 13485:2016

Certification

MDSAP

EU MDR 2017/745

ISO 13485:2016

Certification

EU MDR 2017/745

EU MDR 2017/745

EU MDR 2017/745

Certification

21 CFR 820

ISO 9001:2015

EU MDR 2017/745

Working with FDA for site registration and compliance

ISO 9001:2015

ISO 9001:2015

ISO 9001:2015

Certification

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Remediation Services

ISO 13485:2016

Leading to Certification

MDSAP

Leading to Certification

EU MDR 2017/745

Leading to Certfifation

21 CFR 820

Working with FDA for site registration and conformity

ISO 9001:2015

Leading to Certfication

Quality System (QMS) Upgrading

ISO 13485 to ISO 13485:2016

Certification

ISO 13485:2016 to MDSAP

Certification

ISO 13485:2016 to EU MDR 2017/745

Certification

21 CFR 820 to ISO 13485:2016

Certification

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

Working with FDA for site registration and compliance

ISO 9001 to ISO 9001:2015

Certification

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QMS/QSR Gap Analysis

ISO 13485 to ISO 13485:2016

Leading to Certification

ISO 13485:2016 to MDSAP

Leading to Certification

ISO 13485:2016 to EU MDR 2017/745

Leading to Certification

21 CFR 820 to ISO 13485:2016

Bridging the gaps to achieve compliance leading to Certification

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

Working with FDA for site registration and compliance

ISO 9001 to ISO 9001:2015

Leading to Certification

Contact Us For A Quote!

QMS and QSR - Auditing (Internal and External)

ISO 13485 to ISO 13485:2016

ISO 13485:2016 to EU MDR 2017/745

ISO 13485 to ISO 13485:2016

Preparing the Company for Certification Audit

ISO 13485:2016 to MDSAP

ISO 13485:2016 to EU MDR 2017/745

ISO 13485 to ISO 13485:2016

Preparing the Company for Certification Audit

ISO 13485:2016 to EU MDR 2017/745

ISO 13485:2016 to EU MDR 2017/745

ISO 13485:2016 to EU MDR 2017/745

Preparing the Company for Certification Audit

21 CFR 820 to ISO 13485:2016

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

ISO 13485:2016 to EU MDR 2017/745

Preparing the Company for Certification Audit

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

Preparing the Company for Certification Audit

ISO 9001 to ISO 9001:2015

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

21 CFR 820 to ISO 13485:2016 & MDR 2017/745

Preparing the Company for Certification Audit

Supplier Audits

Supplier Audits

Supplier Audits

Preparing the Company for Certification Audit

Risk Management System Implementation

QMS Risk Management

Preparing the Company for Certification Audit

Product Development / Product Realization

Preparing the Company for Certification Audit

Design Controls for 21 CFR 820

Preparing the Company for Certification Audit

Purchasing

Preparing the Company for Certification Audit

Supplier Evaluation

Preparing the Company for Certification Audit

CAPA

Preparing the Company for Certification Audit

Nonconforming Materials

Preparing the Company for Certification Audit

Internal Auditing processes

Preparing the Company for Certification Audit

Complaint Handling

Preparing the Company for Certification Audit

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Software Validation

QMS Software Validation

Monitoring and Measurement Software Validation

Production Software Validation

Preparing the Company for Certification Audit

Production Software Validation

Monitoring and Measurement Software Validation

Production Software Validation

Preparing the Company for Certification Audit

Monitoring and Measurement Software Validation

Monitoring and Measurement Software Validation

Monitoring and Measurement Software Validation

Preparing the Company for Certification Audit

510K Readiness and Submission

Preparation

Preparing the Company for device approval 

Application Review

Preparing the Company for device approval 

Submission

Preparing the Company for device approval 

Contact Us For A Quote!

Technical Documentation Readiness

Preparation

Application Review

Application Review

Preparing the Company for device approval 

Application Review

Application Review

Application Review

Preparing the Company for device approval 

Submission

Application Review

Submission

Preparing the Company for device approval 

Contact Us For A Quote!

Contact Us For A Quote!

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