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About Us

Over 30 Years di experience in Medical & Pharmaceutical Life science

Since 1987 Effetre, among the first in Italy in this area supports its customers with a wide range of services in Regulatory Affairs & Quality.

The team offers knowledge & tailored solutions in development, clinical, regulatory & compliance in international (EU, FDA, SFDA, NMPA, ARTG, MHRA) Medical Devices & IVDs Regulation assessment.

Our vocation is for small business companies "We believe that small businesses play a significant role in the global economy" and can compete thanks to the increasingly accessible diffusion of digital technologies and the flexibility that allows them to seize emerging opportunities more quickly."

The company operates internationally with absolute autonomy and independence.

  • Medical Devices & IVDs Expert
  • Full service Regulatory Affairs
  • Outsourcing
  • Regulatory legal assistance
  • SW Solution & Validation
  • Artificial Intelligence (AI) Small Business Project
Our Services

Our know how ensure certain times and budgets in the projects

We help our clients in their journey throughout the entire device regulatory lifecycle. We offer the guidance you need to navigate through complex regulatory requirements. Quality assurance and regulatory affairs can hardly be separated: we offers you the complete package. We support you during the entire life cycle of your products.
Our resources offer extensive regulatory affairs knowledge and expertise to support your projects in an efficient and pragmatic manner.

Regulatory Affairs

  • Technical documentation
  • Clinical and performance evaluations
  • Authority Registration
  • Post-market surveillance and vigilance
  • Legal Support

Quality Assurance

  • Quality management system QMS 13485_ GMP
  • Qualification and validation

Software Services & Solutions

  • Label IFU
  • Validated electronic quality management system (QMS)
  • Software Validation
  • Artificial Intelligence (AI) Small business project

Training

We offers effective and high-quality personalized training by designing tailor-made courses for customer.

We help our clients in their journey throughout the entire device regulatory lifecycle.

All Services
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Company Overview

Effetre is a company that was founded with the aim of pursuing a business linked to the development of a series of services linked to the research, engineering and design of products, systems and technologies in the Medical Devices sector. The company operates internationally with absolute autonomy and independence offering specific quality certification and validation services.

  • Values
  • Flexibility
  • Reliability
  • Fairness
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Our Resources

Our Resources

The company was founded with the intention of making available to customers the technical skills and professional experiences that each of us has gained during the course of many years of activity.


The company resources are made up of competent and motivated professional figures, coming from different fields, perfectly integrated and able to operate in multiple company realities.


The desire to combine skills and multiply effects has led to the creation of a team oriented towards the provision of high quality services.


The company makes use of a network of external consultants with different specific skills who are involved in projects as needed.

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