Quality Consulting

MedTech Quality Consulting – From SOPs to Audit Readiness

ISO 9001:2015 – General QMS Certification

ISO 9001:2015 is the global standard for Quality Management Systems across all industries. At D2R Global Consulting, we support organizations in achieving ISO 9001 certification through a step-by-step approach:

Gap assessment of current practices
Development of SOPs and QMS documentation
Conducting internal audits and corrective action planning
Preparation for third-party certification audits
This certification improves operational efficiency, customer satisfaction, and enhances global business credibility.

ISO 13485:2016 – Medical Devices & Diagnostics

ISO 13485:2016 is the international standard for QMS in the medical device and diagnostic sectors. D2R Global Consulting provides full-cycle support, including:

Design control and risk management setup
Documented traceability of product life cycle
Implementation of post-market surveillance (PMS)
Audit readiness for certification bodies and regulatory agencies

We help clients meet global compliance for EU MDR, US FDA, Health Canada, and more.

Quality Management System Regulation (FDA)

The proposed QMSR by FDA aligns 21 CFR 820 with ISO 13485. D2R bridges regulatory expectations by:

Performing gap assessments between FDA QSR and ISO 13485
Updating procedures to meet QMSR draft expectations
Supporting compliance for US FDA submissions

This ensures alignment with both domestic (FDA) and international quality system standards.

Medical Device Single Audit Program (MDSAP)

MDSAP enables a single audit to meet requirements of USA, Canada, Australia, Brazil, and Japan. D2R offers:

MDSAP documentation gap analysis
QMS adjustments aligned to multiple jurisdictions
Mock audits and CAPA implementation
Submission support for MDSAP-recognized auditing organizations

Achieve global market access with a unified regulatory approach.

FDA 21 CFR 820 Implementation

We help medical device companies establish a 21 CFR Part 820-compliant QMS, including:

Creation of Device Master Records (DMR) and Design History Files (DHF)
Implementation of CAPA, complaint handling, and audit trail systems
Readiness for FDA inspections and premarket submissions

Ensure full FDA QSR compliance for Class I, II, and III devices.

GLP (Good Laboratory Practices)

D2R assists preclinical labs and diagnostic companies in achieving GLP compliance, covering:

Sample traceability and data integrity
Equipment calibration and maintenance protocols
SOPs for non-clinical study execution.

GLP compliance ensures acceptance of data for regulatory submissions globally.

GCP (Good Clinical Practices)

For CROs and sponsors, we implement ICH-GCP, CDSCO, and FDA GCP standards, including:

Site SOP development
Investigator training and AE/SAE tracking systems
Ensuring data confidentiality and regulatory filing readiness

Build robust GCP systems to support clinical trials and regulatory approvals.

GMP (Good Manufacturing Practices)

We help healthcare product manufacturers achieve GMP compliance through:

Facility layout and cleanroom protocol development
Batch record documentation and process validation
Quality audits and training programs

Comply with national and global GMP regulations for medical devices and diagnostics.

ISO 27001:2022 – Information Security

ISO 27001:2022 ensures data protection and cybersecurity. D2R supports digital health and SaMD firms with:

Information risk assessments and access control policies
Implementation of data encryption, backup, and disaster recovery
Compliance with HIPAA, GDPR, and other frameworks

Secure sensitive health data with internationally recognized controls.

ISO 15189:2022 – Medical Laboratories

We help diagnostic labs achieve ISO 15189:2022 accreditation by:

Designing QMS for pre-analytical to post-analytical phases
Developing SOPs, EQA programs, and competency training modules
Preparing for NABL assessments and accreditation audits

Assure high-quality, clinically valid laboratory services.

ISO 17025:2017 – Biological Testing of Laboratories

D2R supports laboratories conducting biological, chemical, or mechanical testing to attain ISO 17025:2017 by:

Establishing method validation and uncertainty estimation
Setting up traceability and proficiency testing systems
Preparing for audits by NABL or ILAC-recognized bodies

Demonstrate technical competence with ISO 17025 accreditation.

NABH Accreditation for Hospitals

We help hospitals and clinics meet NABH accreditation standardsthrough:

Implementation of patient safety protocols
SOPs for clinical and non-clinical services
Internal audits and mock NABH inspections
Enhance hospital quality, safety, and national recognition.

CAP Accreditation for Diagnostic Labs

CAP accreditation enables labs to meet global clinical standards. D2R provides:

CAP-compliant documentation and quality manual setup
Staff training and audit preparedness
QC program implementation for pathology and clinical labs
Position your lab for international credibility and collaboration.

AABB for Blood Banks

D2R helps blood banks meet AABB standards, supporting:

Donor and transfusion traceability systems
Development of quality programs and SOPs
Audit readiness for AABB inspectors
Achieve high-quality blood services and international acceptance.

DUNS Registration

A DUNS number is essential for US FDA registration and global procurement. We assist with:

Documentation collection and validation
Application filing and coordination with Dun & Bradstreet
Secure your global business identity with a verified DUNS number.

DSIR Registration (R&D Units)

DSIR Certification is an essential recognition from the Department of Scientific and Industrial Research (DSIR), under the Ministry of Science & Technology, Government of India, for companies engaged in in-house R&D activities. This certification allows companies to claim tax benefits under Section 35(2AB), avail customs and excise duty exemptions, and become eligible for various government R&D funding schemes.

At D2R Global Consulting, we specialize in helping innovation-driven organizations achieve DSIR registration for R&D units with a structured, step-by-step approach:

Step-by-Step DSIR Certification Process

Eligibility Assessment- We evaluate your organization’s R&D infrastructure, staffing, and projects to confirm DSIR eligibility.
Document Preparation- We provide DSIR-compliant templates and assist in compiling all required documents—R&D policy, facility layout, staffing details, equipment list, project reports, and financials.
Application Filing- We prepare and submit the complete DSIR application to the DSIR office, ensuring accuracy and compliance.
Liaison and Follow-up - We engage directly with DSIR officials, respond to queries, and keep your application on track.
Inspection Readiness Support - We conduct mock audits, gap assessments, and train your team for DSIR site inspections.
Approval and Recognition - DSIR approval is typically granted within 4 to 6 months post submission, depending on review timelines and inspection outcomes.