I3infotek is focused on delivering services and products that enable our clients to achieve a higher level of success.
I3infotek is a company built on the philosophy that honesty matters, experience counts and partnerships bring mutual success.
Built on a foundation of quality and innovation, the delivery of these services and products is driven by the commitment to our colleagues and the strength of the relationships between our company and our clients.
I3infotek is specialized in providing services to various clients in Healthcare Industry in the areas of Quality Engineering, Manufacturing, Design and New Product Development, Product Line Transfer, Product Line Implementation, Process Validation, Equipment Qualification, Computer System Validation, Drug Safety and Regulatory Affairs.
I3infotek specialized in Engineering, Quality and Compliance Services including:
- Process Validation
- Method Validation
- Design Control
- Remediation of Quality Systems and records, including:
- CAPA files/records
- Complaint files/records and investigation
- Risk Management documentation
- Design History File remediation
- Technical File and Design Dossier updates
- Product and Process Controls
- Supplier Quality files
- And much more…
With our proven “Balanced Team” approach, we provide the correct mix of engineers from Mechanical, Electrical, Biomedical and Life Science background technical to address your regulatory and quality compliance issues. A team of young, tech-savvy engineers, led by one or two technical managers, is a team of roll-up-our-sleeves.
Our customers have raved about our approach and have thoroughly enjoyed working with our teams.
I3infotek is honored to have partnered with many medical device, pharmaceutical and Biotech manufacturers, assisting them with some of the technical services mentioned above.
Medical Devices that we are specialized in:
- General Surgery
- Spinal & Orthopaedic
- Urological & Urogynecological
- Diagnostic Devices
- Medical Device Equipment Manufacturing
- Surgical Equipment