IZiel Healthcare

IZiel Healthcare

Business Consulting and Services

Minneapolis, MN 7,543 followers

Empowering Medical Device Companies with expert Engineering, Software, Quality, and Regulatory Solutions for Innovation.

About us

IZiel Healthcare is an Engineering, Software & Regulatory Services provider working successfully with global medical device manufacturers from our offices in USA & India. Our engineers are trained as per Design for Six Sigma – Black Belt Level and have completed various projects in Design, Process Validation, QMS Documentation, Regulatory Approvals & Acquisition Integration for Class I, IIa, IIb & III Products. We leverage statistical & data-driven methods, domain knowledge & robust work planning methodology to achieve an optimized product development processes for guaranteed success. IZiel Healthcare provides services in: Design - Systems Engineering and Requirements Management - Transfer Function Development - Predictive Engineering - 3D Modelling & Finite Element Analysis (FEA) - Design Controls Process & Software Validation - PVMP - IQ, OQ, PQ - Test Method Validation (TMV) - Productivity Improvement - Software Validation (IEC 62304) Risk Management - ISO 14971 based Risk Management - FMEA and FTA Based Product Risk Analysis - Quantitative Risk Management Expertise Quality Management Systems and CAPA - QMS Documentation with Procedures & Templates - CAPA (Corrective & Preventive Action) Regulatory - USFDA & CE Approvals - MDD – MDR Conversion - Clinical Evaluation Report (CER) - European Authorised Representative (EAR) Remediation - Resolve Observations (Form 483), Warning Letters etc - Product Remediation Training - Training – DFSS Methodologies and Engineering Topics

Industry
Business Consulting and Services
Company size
51-200 employees
Headquarters
Minneapolis, MN
Type
Partnership
Founded
2016
Specialties
Medical Device Design, Design Engineering, Process Development, Process Engineering, Design Validation, Process Validation, Risk Management, Market Development, Regulatory Services, Software Validation, Cybersecurity, and Gobal medical device manufacturers

Locations

  • Primary

    121 Washington Avenue North

    Suite 306

    Minneapolis, MN 55401, US

    Get directions

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