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Quality Management System for Medical Devices
Implement ISO 13485, CPAKB, and CDAKB systems to ensure compliance, streamline processes, and maintain consistent product quality.
Regulatory Due Diligence and Product Registration
Navigate complex global and local regulations with clear strategies, complete dossiers, and efficient approval pathways.
Product Development and Compliance
From concept to launch, align design, testing, and documentation with international standards and market requirements.
Manufacturing Process Engineering and Validation
Design, qualify, and validate manufacturing processes to meet regulatory standards and ensure reliable, scalable production.
We Work with you to Make your Product a Reality. to Make it accessible. to Make it Impactful.
At Medvicer, we work with Indonesian and international medical technology companies to navigate standards, regulations, and market access from end to end.
Our focus is on medical device quality and regulatory compliance — including ISO 13485 and GMP (CPAKB) implementation, regulatory approvals, product compliance, process validation, and practical quality solutions that scale with your growth. We combine local execution with global expertise to help you move faster, with confidence.
Supported by Our Consultants
Service Model
Consulting Services
Consulting Services
- Quality Management Systems and GxP
- Regulatory Due Diligence and Product Registration
- Product Development and Compliance
- Manufacturing Process Engineering and Validation
Outsourced QA/RA as a Service
Outsourced QA/RA as a Service
- Outsourced Quality Assurance
- Outsourced Regulatory Affairs
- Outsourced Product Compliance
Authorized Representative
Authorized Representative
- Indonesia
- ASEAN
- European Authorized Representative (EAR)
- US Agent
Industries and Stakeholders We Serve
Medical Device We Handle
Consumable Medical Device
Covers single-use and sterile devices such as syringes, catheters, and dressings — focusing on sterilization validation, biocompatibility, and packaging integrity.
Medical Electrical Equipment
Includes powered equipment like patient monitors, diagnostic imaging, and therapy devices — emphasizing electrical safety (IEC 60601), EMC testing, and software validation.
In-Vitro Diagnostic
Encompasses reagents, analyzers, and rapid test kits — focusing on analytical and clinical performance evaluation, stability studies, and labeling compliance.
Software as a Medical Device
Applies to standalone medical software — addressing software lifecycle (IEC 62304), usability engineering, cybersecurity, and clinical evidence requirements.
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What Our Customers Say?
Consultancy for Clinical Evaluation Report
You need the right direction
for your product quality and regulatory compliance, we’ll help you do that.
Feeling safe and confident to work with Medvicer
