Our Roots

SteriLandBio was founded in 2020 from the collaboration and friendship of professionals who had shared many years of work, projects and experience in the medical device industry. 

Before becoming consultants, we worked inside medical device companies, supporting R&D, Quality Assurance, Regulatory Affairs and Operations teams in the development, validation, certification and life-cycle management of medical devices.

This is what makes our approach different.

We understand the technical and regulatory requirements, but we also understand the daily challenges of manufacturers: limited resources, project timelines, audit pressure, documentation gaps, design changes and the need to make decisions that are both compliant and practical.

For this reason, we work as an extension of our clients’ teams, providing clear guidance, solid technical support and pragmatic solutions tailored to each project.

Our Experience

Our experience includes continuous interaction with medical device manufacturers, competent authorities, regulatory bodies and leading Notified Bodies.

We support companies in designing, certifying, manufacturing and distributing safe and effective medical devices across all geographical markets, including, for example, Europe under the MDR, the United States through FDA requirements, Japan through PMDA expectations and China through CFDA/NMPA requirements.

This international perspective allows us to help manufacturers build robust technical documentation, define validation strategies, strengthen quality management systems and prepare for certification or regulatory review.

Our objective is to help clients anticipate expectations, reduce unnecessary iterations and manage regulatory or certification challenges with a clear, structured and scientifically sound approach.

Our Qualifications

ISO 13485 certified auditors

ISO 17025 auditors

Biological evaluation specialists

Sterilization validation experts

Medical writers

Packaging validation experts

Microbiology experts

Our Network

SteriLandBio is supported by a trusted network of qualified collaborators with complementary expertise in regulatory affairs, quality management, supplier quality, design control, risk management and project management.

This allows us to build the right team around each project and provide integrated support without losing the flexibility and direct relationship that characterize our way of working.

The Way We Work

Understand the need.
We start from the client’s context, objectives and constraints.

Define the strategy.
We identify the most suitable solution and build a practical action plan.

Support implementation.
We work with the team to prepare documentation, close gaps and manage technical or regulatory questions.

Stay alongside the client.
We provide continuous support to help the business move forward smoothly and confidently.