Certified Medical Device Manufacturing Excellence
MyMedic Innovation Sdn Bhd is a certified manufacturer of disposable medical devices, recognized for manufacturing excellence and rigorous quality standards. Our facilities and manufacturing processes are certified to ISO 13485:2016 and ISO 11135:2014 by SIRIM QAS International, with international recognition from IQNET. These certifications are your assurance that every product meets the compliance requirements healthcare procurement professionals demand.
We serve healthcare institutions across Malaysia and the region with a comprehensive range of clinical products spanning 11+ product categories—from surgical suction sets and circumcision devices to oxygen therapy systems, wound dressing kits, diagnostic tools, and specialty examination equipment. Every product is manufactured to the highest standards of safety, sterility, and compliance.
Our clinical expertise spans multiple specialties: surgical and operating room care, obstetrics and gynecology, urology, wound and respiratory care, diagnostic and laboratory services, and infusion and infection control. One trusted supplier for multiple departments—reducing procurement complexity while ensuring consistent quality standards across your entire healthcare facility.
Manufacturing Excellence & Certifications
MyMedic's facilities and manufacturing processes meet the strictest international standards for medical device quality management and sterilization. Our certifications ensure every product meets global healthcare procurement requirements.
ISO 13485:2016 Quality Management System
Our facilities and manufacturing processes are certified to ISO 13485:2016, the international standard for quality management systems specific to medical devices. This certification ensures that every stage of production—from material selection through final sterilization—adheres to rigorous controls that protect product integrity and patient safety.
What this means for procurement: ISO 13485 compliance is a mandatory requirement for healthcare institutions and procurement teams evaluating medical device suppliers. It demonstrates our commitment to consistent quality, traceability, and continuous improvement across all manufacturing operations.
ISO 11135:2014 Sterilization Compliance
All MyMedic disposable medical devices undergo sterilization processes validated to ISO 11135:2014, the international standard for steam sterilization of medical devices. Our sterilization protocols are rigorously tested and documented to ensure complete elimination of microorganisms while preserving product functionality.
What this means for procurement: Infection control is critical in healthcare settings. ISO 11135 certification guarantees that every device leaving our facility meets the sterilization assurance level required by hospitals, clinics, and surgical centers. This reduces risk and ensures compliance with infection prevention protocols.
SIRIM QAS International & IQNET Recognition
MyMedic holds certification from SIRIM QAS International, Malaysia's premier quality assurance body, with international recognition from IQNET. This dual certification affirms that our quality management system meets both Malaysian healthcare standards and international best practices.
What this means for procurement: SIRIM QAS certification is recognized across Southeast Asia and internationally, giving healthcare procurement teams confidence that MyMedic meets stringent local and global compliance requirements. IQNET recognition ensures our certifications are valid and audited to international standards.
Medical-Grade Materials & Non-Toxic Manufacturing
Every MyMedic product is manufactured from medical-grade, non-toxic materials that meet international biocompatibility standards. We source materials from approved suppliers and maintain strict specifications to ensure no harmful substances come into contact with patients or healthcare staff.
What this means for procurement: Healthcare institutions can trust that MyMedic devices are safe for patient contact and clinical use. Our commitment to non-toxic materials reduces liability risk and supports your facility's patient safety protocols.
Rigorous Testing & Quality Control
MyMedic implements comprehensive testing and quality control protocols at every stage of manufacturing. From incoming material inspection through final product validation, our processes are designed to catch and eliminate defects before products reach your facility.
What this means for procurement: Rigorous quality control reduces the risk of product failures, recalls, or complications in clinical settings. Your procurement team can confidently specify MyMedic products knowing they've been thoroughly tested and validated for reliable performance.
Compliance at a Glance
Our certifications and manufacturing standards are your assurance that MyMedic meets the compliance requirements your healthcare institution demands. Ready to source certified medical devices from a trusted Malaysian manufacturer?
MessageComprehensive Product Portfolio Across Clinical Specialties
MyMedic manufactures and supplies a diverse range of disposable medical devices serving multiple departments within healthcare institutions. From operating rooms to diagnostic labs, our product categories address the full spectrum of clinical needs.
Surgical & Operating Room
Surgical Fluid Suction Sets and connecting tubes designed for intraoperative use and fluid management during surgical procedures.
Obstetrics & Gynecology
O&G Examination Devices supporting maternal health screening and gynecological assessments.
Surgical Specialties
Circumcision Devices (RapideClamp) offering faster, safer surgical techniques with minimal recovery time.
Urology Care
Specialized urology devices addressing the unique needs of urological care and treatment.
Wound & Respiratory Care
Wound Dressing Kits and Oxygen Therapy Devices supporting patient recovery and respiratory management.
Diagnostic & Laboratory
Transmission Gels, Specimen Management Devices, and diagnostic tools for imaging and lab analysis.
Infusion & Infection Control
Infusion Series and Disinfectant Series ensuring safe IV therapy and rigorous infection prevention protocols.
One trusted supplier for multiple departments—reducing procurement complexity and ensuring consistent quality standards across your entire healthcare facility.
Ready to Partner with MyMedic?
Our sales team is ready to support your healthcare facility's procurement needs. Whether you need pricing for bulk orders, product specifications, or certification documentation, we're here to help.
Message Our Sales Team
Speak directly with our procurement specialists for immediate support on pricing, product availability, and RFQ submissions.
MessageSubmit an RFQ
Request a quotation for specific products, quantities, and facility requirements. Our team responds with detailed pricing and lead time information.
Business Hours
Monday – Friday: Standard Malaysian business hours
For urgent procurement needs, contact us directly via WhatsApp.
Quick Response
Our sales team responds to inquiries within one business day. WhatsApp contact ensures fastest response for time-sensitive procurement.
A Trusted Partner for Healthcare Procurement
MyMedic is a certified medical device manufacturer with ISO 13485:2016 and ISO 11135:2014 compliance. We serve healthcare institutions across Malaysia with a comprehensive range of disposable medical devices across multiple clinical specialties.
When you partner with MyMedic, you're choosing a manufacturer committed to quality, compliance, and your facility's success. Our team understands the procurement process and is ready to support your bulk orders, facility requirements, and long-term supply partnerships.
Prefer to reach out? Message us via WhatsApp for immediate assistance with your procurement needs.