CENIT Consulting

CENIT Consulting provides regulatory affairs and quality management consulting for medical device manufacturers navigating EU MDR/IVDR and US FDA pathways. The firm serves both hardware and software medical device companies, with particular expertise in devices requiring EU market access and US FDA clearance.

The company offers four primary service lines: regulatory strategy and submissions, external PRRC (Person Responsible for Regulatory Compliance) services under EU MDR Article 15, ISO 13485 quality management system implementation, and US FDA Agent representation for non-US manufacturers. CENIT's approach emphasizes rapid onboarding—typically 3-5 business days for PRRC and FDA Agent services—with structured deliverables including submission-ready documentation, audit preparation, and notified body liaison support.

Notable clients include Cipla, Redcord, and multiple MedTech startups across therapeutic areas. The firm maintains operational experience with ISO 13485, ISO 27001, and ISO 14971 frameworks, with documented expertise in both Class I-III hardware devices and Software as a Medical Device (SaMD) regulatory pathways.

Choose CENIT Consulting when you need operational regulatory support with clear timelines and structured deliverables, not just advisory opinions. The firm's strength lies in turning regulatory requirements into audit-ready documentation—risk management files that trace hazards to controls, technical files organized for notified body review, and QMS implementations that pass ISO 13485 certification audits.

Expect a consultative engagement model that starts with device classification and pathway selection, then moves through submission preparation with weekly check-ins. The PRRC and FDA Agent services provide ongoing regulatory representation with defined SLAs rather than ad-hoc consulting hours.

CENIT Consulting operates exclusively in the medical device sector, with documented expertise across both traditional medical devices (Class I-III hardware) and Software as a Medical Device (SaMD) under EU MDR/IVDR and US FDA frameworks. The firm's practice areas align with the complete medical device lifecycle: regulatory strategy, conformity assessment, PRRC oversight per MDR Article 15, quality management system implementation to ISO 13485, information security under ISO 27001 for connected devices, and post-market surveillance planning. Client work spans therapeutic areas including rehabilitation devices, pharmaceutical delivery systems, and diagnostic platforms.

Medical device manufacturers in Classes I-III and SaMD developers preparing first EU submissions under MDR/IVDR, or seeking US FDA 510(k) clearance. Companies that need external regulatory representation (PRRC or FDA Agent) rather than full-time hires, and organizations requiring ISO 13485 QMS buildout with templates and audit preparation alongside regulatory submission work.