Leverage on our 30 Years of Manufacturing Excellence & impeccable conformance record to internationally recognized standards.
FDA, UL & CE
Having spent 30 years in medical manufacturing, one thing we have accumulated a lot was certifications, and recognizitions for our expertise and excellence. If you are looking for help getting FDA, UL or CE certifications we will be happy to guide you along the way, with process establishment, documentations conformance and step-by-step guidance
Technical Files Construction
We can help you in completing documentation requirements related to:
- Technical Write Ups (Instructional Manual, Operator’s Manual etc)
- Product Construction Details
- Engineering information (BOM, Schematics, Cad Drawings, PCB Layouts, Assembly Instructions)
- Software Validation Records
- Device verification Records
- Device validation: This is normally done thru the Substantial Equivalence documents or by referring to earlier proven clinical studies.
Product Safety & EMI/EMC
Through our Compliance Group we will help guide your product towards meeting requirements listed under EMI / EMC & Product Safety Standards. Whether you are at an early design concept stage, prototyping or preparing for manufacturing, we help analyze, test and assist with any required design or component level changes.
Manufacturing Site Inspection
To keep your product certification valid, manufacturing at a compliant facility that passes yearly inspection, is a must. As we have been ISO13485 compliant for many years, manufacturing with us is an added benefit. However, if the product needs to be manufactured at your end, we are happy to help identify and eliminate GAPs in your processes and manufacturing setup.
SAFETY TESTING EXPERIENCE
IEC 60601-1-1: Safety for Medical Electrical Equipment
IEC 60601-1-4: Safety for Programmable Electrical Medical Systems
IEC 60601-1-8: Test and Guidance for Alarm Systems in Medical Electrical Product
IEC 60601-2-3: Safety and Performance for Short-Wave Therapy
IEC 60601-2-5: Safety and Performance for Ultrasonic Therapy
IEC 60601-2-10: Safety and Performance for Muscle Stimulators
IEC 60601-1-2: Electromagnetic Compatibility Tests
CISPR 11: Industrial, Scientific and Medical (ISM) Radio-Frequency
IEC EN 61000-4-3: Radiated, radio-frequency, electromagnetic field immunity test
IEC EN 61000-4-4: Electrical fast transient/burst immunity test.
IEC EN 61000-4-5: Surge Immunity Test
IEC EN 61000-4-6: Immunity to conducted disturbances, induced by radio-frequency fields