Accelerate CE & FDA Approvals with ISO 13485 Expertise

ISO 13485 Certification Process – Step-by-Step Compliance Guide for Medical Devices & IVDs

Achieving ISO 13485:2016 certification is essential for medical device and in vitro diagnostic (IVD) manufacturers seeking global market access. At Reghelps, we guide companies through the complete certification process—from gap analysis to QMS implementation and audit readiness—ensuring full compliance with ISO 13485 requirements.

This step-by-step guide is designed to help manufacturers understand what’s involved in building a quality management system (QMS) that meets the stringent demands of regulatory authorities like the EU (MDR/IVDR), US FDA (QSR), and other global markets.

ISO 13485 Certification Process – Key Steps to Achieve Compliance

The ISO 13485 certification process involves a systematic approach to developing and maintaining a robust Quality Management System (QMS) tailored to the design, production, and distribution of medical devices and IVDs. At Reghelps, we simplify this journey by breaking it down into manageable steps that align with your business goals and regulatory needs. Our experts ensure your organization is audit-ready and fully compliant with ISO 13485:2016 requirements.

Evaluate your current quality system against ISO 13485 requirements and identify areas that need improvement.
Develop a customized quality manual, procedures, SOPs, and controlled templates for each process.
Implement risk management activities for product lifecycle in alignment with ISO 14971.
Roll out QMS processes across departments with training sessions tailored for QA, RA, production, and management teams.
Conduct internal audits to evaluate compliance, document nonconformities, and initiate CAPA.
Conduct formal management review meetings to assess system effectiveness and resource needs.
Simulate a certification audit to identify final gaps and guide your team through closing them effectively.
Support during Stage 1 and Stage 2 audits with document control, auditor interactions, and issue resolution.

integration of ISO with QMSR and MDSAP – creating smart QMS.

download service brochure

service related FAQ’s

Is GMP compliance mandatory for medical device manufacturers?adminreg2025-08-06T04:26:10+05:30

Is GMP compliance mandatory for medical device manufacturers?

Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.

ISO 13485 certification process

MDSAP certification process

21 CFR 820 and QMSR Consultants

GMP Consultants