How we drive impact

Biomech Innovations is your trusted partner for discreet, expert support in quality management and regulatory affairs within the medical technology sector.

We bring deep, hands-on expertise in medical device development—powered by a genuine passion for applied science and innovation.

We understand your challenges, and we’re here to help. Whether you need interim leadership or practical support, we deliver results across product development, quality assurance, regulatory compliance, and technical marketing—helping your organization not just meet, but exceed industry standards.

From preclinical research to regulatory clearance, we accelerate your journey from concept to market-ready solution.

At Biomech Innovations, we bring a broad entrepreneurial perspective—shaped by hands-on experience across the entire medtech lifecycle. Our approach blends strategic insight with practical execution to optimize your technical documentation, enhance team capabilities, and align your regulatory pathway for success.

Our core strengths span the following key areas:

Product Development
Scientific proof of concept
Quality and Regulatory compliance

PROFESSIONAL PROJECT MANAGEMENT

Product Development (R&D)

  • Bringing RA perspective in development projects.
  • Regulatory and standards gap analysis.
  • Supporting the development of new products/products remediation with focus on aspects of V&V.
  • Documentation, planning and execution of cleaning and sterilisation validations.
  • Documentation, planning and execution of packaging and transport validations.
  • Biological evaluation of medical devices within a risk management process.
  • Technical documentation writing and review/remediation.

Scientific proof of concept

Custom in-vivo preclinical investigations

  • Define objectives and endpoints of the study.
  • Pilot study development and implementation.
  • SOPs and development of specific methods.
  • Support in data analyisis and interpretation.

Scientific investigation and writing

  • Study ideation, planning, monitoring and closing.
  • Biomechanical testing.
  • Scientific manuscripts for peer-reviewed journals.
  • Poster abstract, presentation.

Quality and Regulatory compliance

Ad interim Quality Management

Partial/full Quality System responsibility including NB, customers, and supplier audits.

NC, CAPA and complaints

  • Investigation, assessment and remedying of client complaints and non conformities.
  • Definition of correction and prevention measures according to 21 CFR 820 and ISO 13485.

Medical Device Regulatory Affairs (RA)

  • Product regulatory strategy.
  • 510(k) eSTAR and STED submissions.
  • Dealing with regulatory approval.
  • Execution of international registration and approval (in e.g. Saudi Arabia).

Professional Project Management

I am a certified Project Management Professional (PMP) with over 15 years of experience leading complex projects across highly regulated domains. I specialize in delivering results on time and within budget, while aligning with strategic business goals. My approach combines structured methodologies with adaptable leadership to drive efficiency and innovation. I’ve successfully managed cross-functional teams, multimillion-EUR/CHF budgets, and high-stakes timelines. I offer my expertise to organizations seeking a results-driven project manager committed to excellence.

Your advantage

Agreed – done.

Driven by an entrepreneurial mindset and tempered by real start-up endurance, I combine a relentless focus on delivering results with a deep understanding of design control processes and regulatory logic. I know that execution is everything — and I bring the resilience and structure needed to make it happen.

Contact us

Interested in learning more about how can we work together?

Book today a 1:1 meeting!




    Dr. Stefano Brianza, DVM, PhD, B.Sc Biomed Eng.

    As company owner, I leverage my broad scientific and technical skills to support the entire design control process. I use my regulatory affairs expertise, certified by RAC-Devices, to support the entire product life cycle. I solve problems by applying years of entrepreneurial experience and a broad perspective on products commercialization. I apply my project management expertise, certified by PMP to plan and execute complex and multidisciplinary projects delivering results within scope, time, and budget.