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Quality Management System Regulations (QMSR)

30+ years of experience in QSR and ISO 13485 enable us to implement
cost-effective solutions for QMSR.

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RECENT ARTICLES

Navigating the New York State CLEP Program to Achieve Approvals

Navigating the New York State CLEP Program to Achieve Approvals

Navigating the New York State CLEP Program to Achieve Approvals

Sep 25, 20252 min read

QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026

QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026

QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026

Aug 25, 20252 min read

The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

Feb 5, 20252 min read

2

QMSR/QSR

The FDA's QMSR is effective from February 2026. We can help you to upgrade your current Quality System based on QSR or ISO 13485 or CLIA/CAP.

We have expertise in developing, implementing, and integrating quality systems based on US FDA regulations and international standards including ISO 13485 and CLIA/CAP.

QMSR

Upgrading or establishing Quality System based on QMSR

QMSR Gap Analysis

We can perform gap analysis and develop a plan for QMSR compliance.

ISO 13485

Integrating your Quality System based on QSR, ISO 13485, and CLIA/CAP for CE Marking

Audits

We perform internal, external, and supplier audits to support your quality system.

30 years

Our team members have been serving the life science industry for more than 30 years.

RECENT ARTICLES

Navigating the New York State CLEP Program to Achieve Approvals

Navigating the New York State CLEP Program to Achieve Approvals

Navigating the New York State CLEP Program to Achieve Approvals

Sep 25, 20252 min read

QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026

QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026

QMSR vs. QSR: What’s Changing and How AltaQ Can Help You Make the Transition in Time for 2026

Aug 25, 20252 min read

The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

Feb 5, 20252 min read

2

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