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Nope, as it’s charged by another 3rd party independent audit firm. 

For Brand Owner (OEM):

1st year: RM10,000

2nd & 3rd year: RM6,000

4th year (re-cert year): RM10,000

For Full Manufacturer:

1st year: RM10,000

2nd & 3rd year: RM6,000

4th year (re-cert year): RM10,000

It’s ± RM1500. 

5 years, just like the product license. 

Application fee + License Fee

Class A: RM500 + RM750 = RM1250

Class B: RM250 + RM1000 = RM1250

Class C: RM500 + RM2000 = RM2500

Class D: RM750 + RM3000 = RM3750 

For ISO 13485: every year

For Establishment License: 3 years

For Product License: 5 years 

1. Awareness training 
2. Internal audit training
3. Documentation 
4. Management review 

Yes we do. You can come back to us when you are going for 2nd year audit. 

Fee: RM13,000 + 8% SST / project

Duration: 3 days / project 

Maintenance package is inclusive of: 

a) review the readiness of the “documentation for audit” for the upcoming assessment

b) assist on reflecting any changes / amendment that is necessary for documentation and process

c) advise / rectify any issue arise from previous assessment internally/externally

d) assist on conducting the internal audit

e) coordinate the audit between client & CAB

f) assist on replying NC (if any) followed with the Corrective Action implementation

Yes we do. You can come to us for this service. 

Fee: RM5,000 + 8% SST / project

Duration: Estimated 1 – 2 month 

Yes we do. You can come to us for this service. 

Fee:
1. Class A: RM5000 + 8% SST

2. Class B, C, D: RM9000 + 8% SST 

Upon confirmation and pay 10 days before the commencement: 

• Step 1: Pay for ISO13485 Consultation 
• Step 2: Pay for Medical Device Registration Consultation

PS: Travelling allowance will be bare by client for out-of-Klang Valley consultation project.

Yes we can. Let’s speak further on this. 

ISO 13485 is the international Quality Management System (QMS) standard specifically developed for medical device manufacturers, importers, distributors, and service providers. It ensures medical devices consistently meet customer and regulatory requirements throughout their lifecycle.

ISO 13485 demonstrates regulatory compliance, improves product quality, reduces operational risk, increases customer confidence, and supports access to international market.

Organization involved in the design, manufacture, installation, servicing, distribution, importing, exporting, or storage of medical devices can benefit from ISO 13485 certification.

Although certification itself is not legally mandatory, implementing an ISO 13485-compliant Quality Management System greatly supports compliance with Malaysian Medical Device Authority (MDA) regulatory requirements and international market expectation.

ISO 13485 focuses specifically on medical device regulatory compliance, risk management, traceability, sterile manufacturing, validation, and documentation, while ISO 9001 is a general quality management standard applicable to all industries.

Depending on company size and readiness, implementation typically takes between 3 and 6 months.

Medical device manufacturers, diagnostic device companies, dental device manufacturers, healthcare equipment manufacturers, software as a medical device (SaMD) companies, distributors, importers, and contract manufacturers.

Absolutely. Many startups and SMEs successfully implement ISO 13485 to meet customer and regulatory expectation.

Typical documentation includes:

• Quality Manual
• SOPs
• Risk Management Files
• Device Master Record
• Complaint Procedure
• CAPA Procedure
• Internal Audit Procedure
• Management Review Record
• Training Record
• Validation Record

CAPA stands for Corrective and Preventive Action. It helps organizations identify root causes of problems, prevent recurrence, and continuously improve their Quality Management System.

Risk management involves identifying, evaluating, controlling, and monitoring risks throughout the entire medical device lifecycle to ensure patient safety and regulatory compliance.

Yes. ISO 13485 aligns closely with many FDA Quality System requirements and helps organizations prepare for FDA inspection.

Typical stages include:

• Gap Analysis
• Documentation Development
• System Implementation
• Employee Training
• Internal Audit
• Management Review
• Certification Audit
• Certification

Gap Analysis compares your current Quality Management System against ISO 13485 requirements and identifies areas requiring improvement.

A consultant helps reduce implementation time, avoid costly mistake, improve documentation quality, prepare for audit, and increase certification success rate.

Consultants typically assist with:

• Gap Analysis
• Documentation
• SOP Development
• Risk Management
• Employee Training
• Internal Audits
• Certification Preparation

Yes. Organizations already certified to ISO 9001 can integrate ISO 13485 with their existing Quality Management System.

Yes. ISO 13485 requires personnel to be competent through education, training, skill, and experience.

Internal audits should be conducted at planned intervals, typically once per year, although higher-risk processes may require more frequent audits.

Auditors evaluate documentation, interview employees, review record, inspect processes, and verify compliance with ISO 13485 requirement.

Certification is generally valid for three years with annual surveillance audit.

Document control ensures only approved and current procedures are used while obsolete documents are properly managed.

Traceability enables organizations to identify product history, production batches, distribution record, and affected customers if recalls become necessary.

Yes. Validation is required where process outputs cannot be fully verified by subsequent inspection or testing.

Yes. Companies developing Software as a Medical Device (SaMD) can implement ISO 13485.

Yes. Certification demonstrates commitment to quality, patient safety, regulatory compliance, and continual improvement.

Yes. Many international customers and regulators recognize ISO 13485 certification as evidence of a robust Quality Management System.

Common challenges include documentation development, risk management, employee engagement, supplier control, process validation, and maintaining regulatory records.

Preparation includes conducting a gap analysis, establishing documented procedures, training employees, performing internal audits, resolving nonconformities, and completing a management review before the certification audit.

SMEs can improve operational consistency, meet customer requirements, qualify for more tenders, strengthen regulatory compliance, and build credibility in local and international markets.

A well-implemented ISO 13485 system helps reduce the likelihood of product defects by strengthening design controls, supplier management, risk management, and traceability.

Top management is responsible for providing leadership, establishing quality objectives, allocating resources, ensuring regulatory compliance, and reviewing the effectiveness of the Quality Management System.

Yes. Organizations involved in importing, warehousing, and distributing medical devices often integrate ISO 13485 with Good Distribution Practice (GDP) requirements to strengthen quality management across the supply chain.

A local consultant understands Malaysian Medical Device Authority (MDA) requirement, regional regulatory expectation, and certification practices, while providing practical guidance tailored to local business operation.

Look for consultants with proven implementation experience, knowledge of medical device regulations, successful certification projects, practical training capabilities, and ongoing post-certification support.

Yen Premium Coach Consulting provides practical, hands-on ISO 13485 consulting tailored to your organization’s needs. Services include gap analysis, documentation development, implementation support, employee training, internal audits, certification preparation, and post-certification guidance to help medical device businesses build a compliant and effective Quality Management System.

WhatsApp us at 0175709263 or fill up the form here