Our Roots.

SteriLandBio was born in 2020 from the collaboration and friendship of colleagues who have been working together for more than 10 years in medical device companies supporting the R&D, QA, RA and Operations teams. We are EXPERIENCED professionals in Quality Assurance, Biocompatibility, Microbiology, Packaging & Sterilization validation, DRIVING AND ENABLING TEAMS to design, certify, manufacture and distribute safe and effective medical devices through ALL GEOGRAPHICAL MARKETS (Europe- MDR; US-FDA, Japan-PMDA, China-CFDA).

Extended Team.

We have a network of collaborators that allows us to cover a wide spectrum of services:

• Regulatory professionals: 510k, PMA, MDR&IVDR

• Experienced Quality Management professionals: Certified auditors (ISO13485, ISO 9001), Certified Supplier Quality PROFESSIONAL 

• R&D professionals: Design control, DRM techniques, project management

Our experience.

Continuous interactions with competent authorities (FDA, CFDA, PMDA) and the most important Notified bodies (BSI, TUV SUD, Dekra) provided us the right experience and mindset to help other companies to prepare technical files and quality management systems to get successfully (and rapidly) approval and certification minimizing the number of interactions/deficiencies. 

Our Philosophy.

Flexibility, competence and experience tailored on each customer need.

The way we work.

MEET the client and UNDERSTAND the need.

Study the more suitable SOLUTION.

Propose the ACTION PLAN.

Following the solution IMPLEMENTATION.

Monitor the IMPROVEMENTS.

CONTINUOUSLY SUPPORT to run the business smoothly.