hazard, harm, risk management, medical device development

Strategic Compliance
Partner for Med Tech companies

Welcome to CENIT Consulting, your premier partner for regulatory affairs and information security consulting for medical device manufacturers.

 
 Our experienced consultants are committed to helping your company achieve compliance with regulatory requirements and protect your valuable information from cyber threats.

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With offices in both the EU and USA, we are uniquely positioned to offer our clients a global perspective and unparalleled expertise in the ever-evolving world of regulatory affairs and information security.

 

 

We offer a wide range of services, including MDR and FDA compliance assistance, ISO 13485 implementation/internal audits, PRRC and US FDA Agent services, ISO 27001 implementation/internal audits, risk management and training, documentation support, and much more.

As your trusted partner, we also have partnerships with experts in various aspects of medical device development, including design, clinical trials, and EQMS software, allowing us to offer comprehensive support throughout the entire medical device development process.

 

Contact us today to learn more about how we can support your medical device company and achieve compliance and information security excellence. Let us help you succeed!

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Cybersecurity for medical device manufacturers.

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Our services

Regulatory Affairs

We can offer assistance with your regulatory compliance in several regions throughout the world.

PRRC

CENIT can represent your company for this required position in order to maintain compliance to the EU MDR/IVDR.

US FDA Agent

We can serve as the US agent for medical device manufacturers who do not have a presence in the US.

Quality Management

CENIT can help organizations meet customer, market and regulatory requirements.

Information Security

We can help implement your information security management system (ISMS). Towards your path to ISO 27001 certification.

Human Resources

We offer a wide range of HR Services. We can act as your HR Department or we can advice in HR related issues on a case to case basis.