I am a consultant specialising in medical devices, biotechnology, and IoT-enabled health and consumer products. With a proven track record in regulatory compliance, global manufacturing scale-up, and end-to-end supply chain strategy, I help innovative companies navigate FDA, CE, ISO, and GMP requirements while optimising cost, efficiency, and market readiness. My expertise spans early-stage startups to established manufacturers, delivering product approvals, operational excellence, and risk-managed launches worldwide.

Client and Project Case Studies

Some short examples of my experience and key achievements.

Calcivis IoT Device

  • Developed, implemented and achieved FDA approval of electronics manufacturing in China.
  • Developed, scaled and achieved FDA approval of cGMP biologics manufacturing in Spain.
  • Developed, scaled and achieved FDA approval for product kitting and order fulfilment.
  • Achieved ISO 13485 certification and FDA PMA approval.
  • Validated cold-chain global logistics capability.
  • 35% manufacturing production cost down.
  • Implemented customer order B2B fulfilment to the US/EU.
  • Implemented and validated ERP software.

Aquarate IoT Device

  • Mentored the design engineering team (hardware/software) through DFM and product approvals (CE/UKCA).
  • Developed, implemented, and validated subcontract manufacturing in Lithuania.
  • Implemented kit-to-order and fulfilment process and eCommerce platform.
  • Implemented customer order processes and product logistics and fulfilment to +100 care homes in the UK.
  • ERP implementation and validation.

Eclateral IVD Test

  • Developed the regulatory approval and production strategy for a COVID-19 invitro diagnostic test system including test strip, IoT reader and custom application software.
  • Manufacturing transfer, validation, and scale (hardware and application software combination).
  • Wrote full ISO 13485 quality management system, implemented, and passed UL stage I audit.
  • ERP implementation and validation.

ISO Tracker SaaS

  • Developed risk management plan and software validation protocols and test scrips.
  • Completed software validation to comply the US FDA 21 CFR and EU GMP regulatory frameworks.
  • Met client lead time and budget to release product.
  • Full protocol, test script and report documentation pack created.

Alere Tech (IVD)

  • Global supply chain development to support product launch.
  • Global clinical trial logistics and supply.
  • Cold chain validation and global shipping capability.
  • Kitting process implementation and validation.
  • End-to-end customer order logistics and order fulfilment.

Valneva Vaccines

  • Setup a supply chain for GMP biologics compliance achieving FDA Biologics Licence Approval approval.
  • Setup 3rd party fill-finish contract manufacturing.
  • Developed implemented and validated global cold chain logistics to supply the market and US military supply.

Boundary IoT

  • Project managed the complex hardware/software technology transfer from design to production.
  • Selected, validated and scaled full-service manufacturing in China.
  • Developed and implemented product inventory control, kitting, and order fulfilment to end users (direct B2C eCommerce process).
  • Achieved ISO 9001 certification.
  • ERP implementation and validation.

Inflow ADHD SaaS

  • Audit of all marketing materials (print, socials) and the assessment of software as a medical device (SaMD) classification.
  • Assessment against the regulation and evaluation of NHS digital mental health technology (DMHT)
  • Wrote the indented use of the product is a self-help guide (for ADHD) and not a medical device.
  • Wrote marketing claims standard operating procedure to ensure compliance to non-medical device classification.

Robotical Robot

  • Engineering cost down – product tear down and cost reduction opportunities identified.
  • High-risk components sourced to avoid launch delay.
  • BoM risk assessment to derisk production schedule and control cost of goods.
  • New product manufacturing evaluation, transfer plan and regulatory approval strategy developed via a global tender process.

IntelliDigest Robot

  • Developed ISO 9001 quality management system.
  • Developed investment strategy and pitch deck / business case.
  • Developed contract manufacturing and supply chain.
  • Developed end-to-end bio nutrient logistics network – from waste food to farm.

XSITU IoT

  • Regulatory strategy.
  • Business plan and budgeting process.
  • Manufacturing strategy and contracting.
  • Pitch deck and investment strategy.
  • Quality management system.
  • Hardware and software validation.

Voxblock

  • Regulatory risk assessment
  • Technical file compilation
  • Team training on quality management and supply chain resilience.

My Services

Supply Chain Management

Develop clear, actionable strategies to drive your business forward. We help you define objectives, identify market opportunities, and create robust plans for success and growth.

Regulatory Compliance

Optimise your internal processes, reduce waste, and enhance productivity. Our experts streamline workflows to ensure your operations run smoothly and cost-effectively.

Quality Management System

Gain deep insights into your target markets and identify new avenues for expansion. We equip you with the knowledge to make informed decisions and capture growth opportunities.

Business Systems

Embrace the power of technology to revolutionise your business. We guide you through digital adoption, helping you implement solutions that enhance competitiveness and customer engagement.

Contact me

Contact

07525 780822

Stevenvalentiemail@gmail.com]]