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the right approach

Cateva Solutions LLC is a consulting and contracting firm that integrates both millennial and traditional approaches in the pharmaceutical and health & wellness markets.  Cateva Solutions provides an open and honest workspace for engineers who are willing to successfully support, launch and sustain products in the biotech industry.  Our passion is to launch health care products that have been properly verified and validated, and to successfully launch more products geared towards a diverse and inclusive population.

core values

Compliance, Accountability, Quality, Diversity, and Integrity  

EXPERTISE

•  21 CFR Part 11     21 CFR Part 820 

•  93/42/EEC  •  EN ISO 14971:2019

•  EU MDR 2017/745  •  IMDRF  •  ICH E6 (R2)  •  ICH Quality Guidelines  •  ISO 9001  

•  ISO 13485:2016 & MDSAP  •  NMPA (China FDA)

CERTIFICATIONS

  •  ELM-103 GMP 21 CFR 210, 211  •  Good Clinical Practice  •  ISO 13485 Lead Auditor 

•  Lean Sigma Yellow/Green/Black Belt  • Project Management Professional 

•  Medical Devices Quality Management Systems ISO 13485:2016

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