ISO 13485:2016 WITH MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) AND EU MEDICAL DEVICE REGULATION (MDR) CONSULTANCY

ISO 13485 consultants- Medical and Pharmaceutical

Training, Consulting and Certification Support Services for Medical Device Manufacturers Accessing Global Markets

I. Introduction

The global medical device industry is increasingly regulated by stringent quality management, safety, performance and regulatory requirements. Manufacturers seeking access to international markets must demonstrate not only compliance with ISO 13485:2016 but also conformity with specific regulatory requirements established by authorities in major markets including the United States, Canada, Australia, Brazil, Japan and the European Union.

VINTECOM International provides specialized consulting services for:

ISO 13485:2016 Medical Device Quality Management Systems.
Medical Device Single Audit Program (MDSAP).
EU Medical Device Regulation (EU MDR 2017/745).
EU In Vitro Diagnostic Regulation (IVDR 2017/746).
CE Marking for Medical Devices.
FDA Quality Management System Requirements (QMSR).
Medical Device Risk Management according to ISO 14971.
Technical Documentation and Regulatory Compliance.

Our consulting services help manufacturers establish a robust quality management system, meet regulatory requirements, prepare technical documentation, and successfully obtain international certifications and approvals for global market access.

II. What is ISO 13485:2016?

ISO 13485:2016 is the internationally recognized Quality Management System standard specifically developed for organizations involved in the lifecycle of medical devices.

The standard establishes requirements for:

Design and development.
Manufacturing and assembly.
Sterilization processes.
Packaging and labeling.
Storage and distribution.
Installation and servicing.
Complaint handling.
Post-market surveillance.
Regulatory compliance.

ISO 13485 serves as the foundation for most international medical device regulatory systems and is often a prerequisite for obtaining approvals in major global markets.

III. What is the Medical Device Single Audit Program (MDSAP)?

The Medical Device Single Audit Program (MDSAP) enables a medical device manufacturer to undergo a single regulatory audit that satisfies the quality management system requirements of multiple participating regulatory authorities.

Instead of undergoing separate audits for different countries, manufacturers can utilize one MDSAP audit conducted by an authorized MDSAP Auditing Organization.

The primary objective of MDSAP is to:

Reduce duplicate audits.
Improve regulatory efficiency.
Enhance global harmonization.
Reduce compliance costs.
Strengthen oversight of medical device manufacturers.

Through MDSAP, a manufacturer may demonstrate compliance with regulatory requirements across multiple jurisdictions using a single audit process.

IV. Participating Regulatory Authorities in MDSAP

The MDSAP program is jointly administered by regulatory authorities from several major medical device markets:

Australia

Therapeutic Goods Administration (TGA)

Brazil

National Health Surveillance Agency (ANVISA)

Canada

Health Canada

Japan

Ministry of Health, Labour and Welfare (MHLW)

Pharmaceuticals and Medical Devices Agency (PMDA)

United States

Food and Drug Administration (FDA)

These authorities collaborate to recognize and utilize MDSAP audit results within their respective regulatory frameworks.

Additional regulatory authorities and international organizations may participate as observers or future members as the program continues to expand.

V. Benefits of MDSAP Certification

Organizations implementing MDSAP may obtain significant advantages:

Regulatory Benefits

One audit accepted by multiple jurisdictions.
Reduced regulatory audit duplication.
Faster regulatory review processes.
Improved regulatory confidence.

Business Benefits

Enhanced market access opportunities.
Improved reputation with regulators and customers.
Reduced audit preparation costs.
Increased competitiveness in global supply chains.

Operational Benefits

Stronger quality management systems.
Improved risk management.
Better process control and traceability.
Enhanced regulatory readiness.

VI. EU Medical Device Regulation (EU MDR 2017/745)

Important Regulatory Update

Medical Device Directive 93/42/EEC (MDD) has largely been replaced by Regulation (EU) 2017/745 on Medical Devices (EU MDR).

EU MDR introduces significantly more stringent requirements compared with the former MDD framework.

Manufacturers seeking CE Marking for medical devices in Europe must generally comply with MDR requirements, including:

Clinical Evaluation

Clinical evidence generation.
Clinical performance assessment.
Post-market clinical follow-up.

Risk Management

Application of ISO 14971.
Lifecycle risk assessment.
Benefit-risk analysis.

Technical Documentation

Device description.
Design verification.
Validation reports.
Risk management files.
Clinical evaluation reports.

Post-Market Surveillance (PMS)

PMS Plans.
PMS Reports.
Periodic Safety Update Reports (PSUR).
Vigilance reporting.

Unique Device Identification (UDI)

Product traceability.
Market surveillance support.
Supply chain transparency.

VII. Legacy Medical Devices under 93/42/EEC

Although MDR has replaced MDD, certain legacy devices certified under Directive 93/42/EEC may still be subject to transitional arrangements depending on their certification status and applicable regulatory provisions.

Manufacturers maintaining legacy products should carefully evaluate:

Transition deadlines.
Certificate validity.
MDR compliance requirements.
Notified Body transition strategies.

Professional regulatory guidance is strongly recommended during the transition process.

VIII. ISO 13485 and MDSAP Consulting Process

VINTECOM International provides comprehensive consulting support through the following stages:

Step 1 – Project Scoping and Gap Assessment

Review existing quality systems.
Identify compliance gaps.
Develop implementation roadmap.

Step 2 – Regulatory Requirement Analysis

Applicable market requirements.
Product classification review.
Regulatory pathway determination.

Step 3 – ISO 13485 System Development

Quality Manual.
Procedures.
Work Instructions.
Records and Forms.

Step 4 – Risk Management Implementation

ISO 14971 integration.
Risk assessment.
Risk control measures.

Step 5 – Internal Auditor Training

ISO 13485 Internal Auditor.
MDSAP Audit Requirements.
Regulatory Compliance Auditing.

Step 6 – Internal Audit and CAPA

Internal audit execution.
Nonconformity management.
Corrective action implementation.

Step 7 – Certification and Regulatory Audit Preparation

Certification readiness assessment.
Mock audit activities.
Audit support.

Step 8 – Certification and Market Approval Support

ISO 13485 Certification.
MDSAP Audit Support.
CE Marking Support.
Regulatory Submission Assistance.

IX. Why Choose VINTECOM International?

VINTECOM International provides practical consulting and implementation support for organizations operating within highly regulated industries, including medical devices, pharmaceuticals, biotechnology and healthcare.

Our expertise includes:

ISO 13485:2016.
MDSAP Implementation.
ISO 14971 Risk Management.
EU MDR 2017/745.
EU IVDR 2017/746.
CE Marking.
FDA QMSR Compliance.
Global Medical Device Regulatory Systems.

We support manufacturers, OEM suppliers, contract manufacturers, sterilization providers, packaging suppliers and medical device organizations seeking to strengthen compliance, improve quality performance and successfully access international markets.

Successful implementation of ISO 13485 and MDSAP demonstrates a company's commitment to quality, patient safety, regulatory compliance and continuous improvement while enhancing credibility throughout global medical device supply chains.

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