Company profile
IZiel Healthcare
Empowering Medical Device Companies with expert Engineering, Software, Quality, and Regulatory Solutions for Innovation.
- Industry
- Business Consulting and Services
- Employees
- 161
- Headquarters
- Minneapolis, MN
- Founded
- 2016
- LinkedIn followers
- 10,311
- Office locations
- 1
IZiel Healthcare company summary
IZiel Healthcare is a company in the Business Consulting and Services industry, headquartered in Minneapolis, MN, founded in 2016. On LinkedIn the company has around 161 employees and 10,311 followers. Its listed specialties include Medical Device Design, Design Engineering, Process Development, Process Engineering, Design Validation.
What technology does IZiel Healthcare use?
No technologies detected yet. Warmrank rechecks company websites on a rolling basis.
About IZiel Healthcare
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
Specialties
Where is IZiel Healthcare located?
IZiel Healthcare lists 1 location.
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Frequently asked questions about IZiel Healthcare
What does IZiel Healthcare do?
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
How many employees does IZiel Healthcare have?
IZiel Healthcare has around 161 employees on LinkedIn.
Where is IZiel Healthcare headquartered?
IZiel Healthcare is headquartered in Minneapolis, MN.
When was IZiel Healthcare founded?
IZiel Healthcare was founded in 2016.
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