ISO 13485 Consulting and MDR Conformity Assessment Support at Hong Phat – Medical Device Quality Management System and EU MDR Requirements

Consulting on Medical Device Management Systems in accordance with ISO 13485 and Regulation (EU) 2017/745 (MDR) at Hong Phat Company

VINTECOM provides consulting services for the development, implementation, and assessment of medical device management systems in accordance with ISO 13485, combined with conformity assessment against the requirements of Regulation (EU) 2017/745 (MDR), supporting manufacturers in meeting the conditions for placing medical devices on the EU market.

In the context of increasingly stringent requirements for medical device quality and safety management, particularly under the regulatory requirements governing supply chains for the EU market, establishing a management system compliant with ISO 13485:2016 while simultaneously addressing the regulatory requirements of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) is an important foundation for medical device manufacturers targeting both the Vietnamese and international markets.

1. Diverse Medical Device Manufacturing Scope at Hong Phat Company

Hong Phat Company has a relatively broad medical device manufacturing scope, covering equipment used for sterilization, instrument processing, patient care, laboratory applications, infection control, medical waste treatment, and medical lighting.

The products within the scope of the consulting project include:

• Medical steam sterilizers;
• Medical sterilization drying cabinets;
• Incubators – microbiological culture incubators;
• H₂O₂ plasma sterilizers;
• Medical endoscope drying and storage cabinets;
• Medical suction equipment;
• Medical patient beds;
• Electric medical beds;
• Sterile medical hand-washing sinks;
• Class II biological safety cabinets;
• Medical instrument washers;
• Traditional herbal medicine decoction machines;
• Distilled water production equipment;
• Medical waste sterilizers;
• Medical waste shredders/cutting machines;
• Medical waste incinerators;
• Medical instrument boiling sterilizers;
• Medical examination lights;
• Gooseneck examination lights;
• Infrared lamps;
• Ultraviolet lamps.

Given that these product groups have different intended purposes, technologies, risk levels, and safety and performance requirements, the implementation of ISO 13485 and MDR needs to follow a product-, risk-, and applicable regulatory requirement-based approach, rather than simply establishing a common documentation system for the entire organization.

2. ISO 13485 – The Foundation of the Medical Device Quality Management System

ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes is an international standard specifically designed for the quality management systems of organizations involved throughout the life cycle of medical devices.

During the consulting project at Hong Phat, VINTECOM focuses on developing a management system covering processes that affect the quality, safety, and conformity of medical devices, including:

• Determination of the context and scope of the management system;
• Control of documented information and records;
• Management responsibility and leadership;
• Resource and personnel competence management;
• Infrastructure and work environment controls;
• Medical device design and development management;
• Product risk management;
• Supplier and purchasing process controls;
• Production process controls;
• Validation of processes;
• Control of monitoring and measuring equipment;
• Identification and traceability;
• Control of nonconforming products;
• Complaint handling;
• Incident reporting and handling;
• Corrective and preventive actions;
• Monitoring, measurement, and continual improvement of the management system.

In particular, for medical devices, the quality management system is not only intended to ensure that products meet technical requirements, but must also ensure safety, performance, and compliance with applicable statutory and regulatory requirements throughout the entire product life cycle.

3. Integration of MDR Requirements into the Medical Device Management System

In addition to ISO 13485, VINTECOM supports Hong Phat in addressing the requirements of Regulation (EU) 2017/745 (MDR) for individual products and product families.

One of the key approaches is to establish a systematic sequence:

Intended Purpose → Device Classification → MDR Classification Rules → Safety and Performance Requirements → Risk Assessment → Technical Documentation → Clinical Evaluation → Conformity Assessment → PMS/PMCF

Integrating MDR requirements into the ISO 13485 management system helps the company avoid a situation where the quality management system and product regulatory documentation are developed as two separate and disconnected systems.

Key areas include:

Medical Device Classification

Determining whether devices fall into Class I, Class IIa, Class IIb, or Class III according to the classification rules in Annex VIII of the MDR, based on intended purpose, duration of use, invasiveness, active/non-active characteristics, and other relevant characteristics.

Safety and Performance Requirements

Identifying and demonstrating conformity with the General Safety and Performance Requirements (GSPR) specified in Annex I of the MDR.

Risk Management

Establishing the linkage between product risk management and the processes of design, manufacturing, clinical evaluation, and post-market surveillance, with ISO 14971 serving as an important standard for medical device risk management.

Technical Documentation

Developing and controlling Technical Documentation in accordance with Annex II and Annex III of the MDR, including information on the device, design and manufacturing, verification/validation, risk management, GSPR, PMS, and other relevant conformity evidence.

4. Clinical Evaluation – A Key Requirement for Hong Phat's Product Portfolio

With a diverse range of products, Clinical Evaluation is one of the key areas that needs to be systematically addressed.

According to Article 61 and Annex XIV of the MDR, manufacturers are required to conduct a clinical evaluation appropriate to the characteristics, classification, intended purpose, and risks of the device.

Importantly, Clinical Evaluation does not mean that every medical device must undergo a Clinical Investigation involving patients.

Depending on the product, clinical evidence may be considered from multiple sources, such as:

• Scientific data and literature;
• Existing clinical data;
• State of the Art;
• Data from equivalent devices, where the applicable conditions are met;
• Relevant verification/validation and performance testing data;
• PMS data;
• PMCF data, where applicable;
• Clinical Investigation, where necessary.

For Hong Phat, Clinical Evaluation should be approached according to product families, while the specific characteristics and risks of each model should be assessed separately where necessary.

For example, for medical sterilizers, important evidence may focus on sterilization effectiveness, process validation, biological/chemical indicators, cycle parameters, and equipment safety.

For medical suction machines, attention should be given to suction performance, vacuum pressure, flow rate, fluid collection capability, alarm functions, and risks associated with patients.

For electric medical beds, the evaluation should address mechanical safety, electrical safety, load-bearing capacity, entrapment prevention, positioning functions, and usability.

For medical examination lamps, infrared lamps, and ultraviolet lamps, the intended purpose and risks associated with optical radiation, heat, exposure, and user safety should be considered.

Therefore, VINTECOM does not apply the same Clinical Evaluation methodology to all products. Instead, the methodology is developed according to the characteristics and risks of each group of medical devices.

5. Development of Technical Documentation and Product Files

One of the key objectives of the consulting program is to support Hong Phat in establishing a product documentation structure that meets applicable medical device regulatory requirements.

The product documentation may include:

Product Specification

→ Intended Purpose

→ Device Classification

→ Applicable Standards & Regulations

→ Risk Management File

→ Design & Development Records

→ Verification & Validation

→ GSPR Checklist

→ Clinical Evaluation / CER

→ Labeling & IFU

→ Technical Documentation

→ PMS Plan & PMS Report

→ PMCF Plan/Report, where applicable

→ Declaration of Conformity

Establishing clear links among these documents enables the company to consistently demonstrate that:

The device is designed for its intended purpose → risks are identified and controlled → safety and performance requirements are fulfilled → appropriate evidence is generated → documentation is controlled → the product is monitored throughout the post-market phase.

6. Integrating ISO 13485 and MDR into an Integrated Management System

VINTECOM recommends that Hong Phat develop its system based on the following principles:

ISO 13485 = Quality Management System

MDR = EU Legal and Regulatory Framework for Medical Devices

ISO 14971 = Risk Management

Clinical Evaluation = Clinical Evidence

Technical Documentation = Evidence of Conformity

PMS/PMCF = Post-Market Surveillance

These components should be interconnected rather than implemented independently.

Risk Management: Identifying the risks that need to be controlled

Design & Development: Defining design requirements and verification/validation activities

Clinical Evaluation: Evaluating clinical evidence and benefit-risk

GSPR Assessment: Demonstrating conformity with the MDR

Technical Documentation / PMS / PMCF: Updating Risk Management and Clinical Evaluation based on relevant information and post-market data.

7. VINTECOM International's ISO 13485 and MDR Consulting Services

VINTECOM International provides consulting services aimed at integrating medical device quality management systems with applicable product regulatory requirements for supply chains entering the EU market, such as the MDR, as well as international regulatory requirements. This approach is particularly suitable for medical device manufacturers with multiple product groups sharing similar designs and characteristics (product families).

The scope of support may include:

• Conducting an initial assessment and evaluating the current status;
• Defining the scope of ISO 13485 and applicable EU MDR regulatory requirements;
• Conducting a Gap Assessment;
• Developing the ISO 13485 documented management system;
• Developing product design and development management procedures;
• Establishing Risk Management in accordance with ISO 14971 and developing an MDR Risk Matrix;
• Providing consulting support for medical device classification under the MDR based on the risk level of the device;
• Identifying applicable GSPRs and product standards;
• Providing consulting support for the development of Technical Documentation;
• Providing consulting support for Clinical Evaluation and CER;
• Providing consulting support for PMS and PMCF;
• Consulting on the control and competency evaluation of suppliers;
• Providing consulting support for validation and verification activities to verify and validate medical device processes and products throughout the design and development stages through to mass production;
• Providing awareness training and training on specific ISO 13485 and MDR requirements;
• Providing internal auditor training based on the guidelines of ISO 19011:2018;
• Conducting internal audits of ISO 13485 and MDR medical device management systems;
• Supporting the correction of nonconformities based on RCA methodologies, including 5 Whys, Fishbone Diagram, and 8D;
• Preparing the company for conformity assessment and certification audits.

8. Objectives of the Consulting Program at Hong Phat

Through the consulting program, the objective is not only to help the company achieve ISO 13485 certification and demonstrate the conformity of medical devices with the MDR, but more importantly, to establish a system capable of controlling the entire lifecycle from:

Design Planning and Program Confirmation → Product Design & Development → Process Design & Development → Product and Process Verification & Validation → Mass Production → Inspection/Testing → Conformity Assessment → Technical Documentation → Product Registration in accordance with applicable legal requirements → Placing the Product on the Market → PMS/PMCF → Continual Improvement.

For a company with multiple medical device groups such as Hong Phat, this approach helps establish a consistent and integrated management system with traceable evidence that can be readily expanded to new products and models.

VINTECOM International – Training, Consulting and Conformity Assessment Support Organization for ISO 13485 & MDR Medical Device Quality Management Systems

With experience in consulting on management systems and technical standards for manufacturing enterprises, VINTECOM provides ISO 13485 consulting integrated with Regulation (EU) 2017/745 (MDR) through a practical, product-, process-, and risk-based approach.

Our services are suitable for:

• Medical device manufacturers;
• Medical device development and design companies;
• OEM/ODM manufacturers;
• Companies targeting the EU, US, North American, and UK markets;
• Companies requiring the development of Technical Documentation and Clinical Evaluation;
• Companies preparing for ISO 13485 and MDR assessments.

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☎ VINTECOM International Office in Ha Noi City: 16th Floor - Green Stars City, 234 Pham Van Dong Street, Phu Dien Ward, Hanoi City. Hotline 094-886-5288/ (024) 730-588-58

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