01
Medical device quality systems
End-to-end design, deployment, and certification of Quality Management Systems for Class II and Class IIb medical devices, including FDA, CE, and ISO 13485 frameworks.
Deliverables
- ISO 13485 certification implementation and audit preparation
- 510(k) submission support
- Quality Management System documentation, NCR tracking, and CAPA processes
- Internal and external audit coordination
- Cloud-based QMS deployment for distributed teams
Credibility
At Kovac Biomedics, I deployed a cloud-based Quality Management System for a Class II / CE Class IIb cardiac electrophysiology device and steered the organization to secure ISO 13485 certification in eight months with zero major Non-Conformance Reports across two internal and two external audits — enabling collaboration across teams in the US, UK, and Brazil.
For: MEDICAL DEVICE STARTUPS · WEARABLE HEALTH · REGULATED APPAREL
02
Biobased materials & alternative leather product development
Operational, technical, and strategic leadership for companies developing biobased materials and alternatives to conventional leather, plastic, and synthetics — from prototype through scale.
Deliverables
- Material characterization and mechanical property studies
- Supplier sourcing across UK, European, and Latin American markets
- Sustainability certification roadmaps (USDA 100% Biobased, OEKOTEX, B-Corp, ISO 9001)
- Customer acquisition pipeline development for emerging materials
- Investor and pitch presentation support
Credibility
At Biophilica, the London startup behind Treekind, I led operations as the company scaled a 100% biobased leather alternative made from green waste. The work spanned wholesale strategy across UK and European markets, internal research on mechanical properties and seam strength, Health & Safety protocol establishment, and the full certification stack. Featured on the No Ordinary Cloth podcast (Ep. 2) and Carbon Times.
For: ALT-LEATHER STARTUPS · BIO-MATERIALS COMPANIES · SUSTAINABLE FASHION BRANDS
03
Technical textile R&D
Research, prototype development, and validation for technical textiles in medical, performance, and protective applications.
Deliverables
- Feasibility studies and material screening
- Prototype design and benchtop validation
- Test protocol development against ISO, ASTM, and AATCC standards
- E-textile integration (sensors, telemetry, smart fabrics)
- Multi-disciplinary team direction across material science, chemistry, and microbiology
Credibility
Spearheaded the launch of three new pioneering testing services at a UK accredited laboratory — Microbiological Environmental Monitoring, Medical Device Material Compatibility, and Air Purification Product Testing — and brought the company through UKAS / ISO 17025 accreditation. Research portfolio spans silver-based antimicrobial textiles, an e-textile shoe insert for diabetic neuropathy with embedded Bluetooth telemetry, auxetic knit prototypes, and three-dimensional textile structures for medical applications.
For: TECHNICAL APPAREL BRANDS · PERFORMANCE WEAR · MEDICAL TEXTILE MANUFACTURERS
04
Antimicrobial textile testing & standards advisory
Protocol design, standards interpretation, and validation of antimicrobial textiles for healthcare, consumer, and protective applications. Independent technical advisory.
Deliverables
- Test protocol design against ASTM E3160, AATCC 100, ISO 20743, ASTM E2149
- Validation study design and execution
- Standards interpretation for marketing claim substantiation
- Training materials and educational content for laboratory teams
Credibility
Master's thesis on the effectiveness and durability of silver-based antimicrobial textiles for the prevention of healthcare-associated infections. Co-author of published research on vaporised hydrogen peroxide compatibility for medical device decontamination in Cogent Engineering. Ongoing voting role on the research committees that shape antimicrobial testing standards.
For: ANTIMICROBIAL GARMENT MAKERS · HOSPITAL TEXTILE VENDORS · HEALTHCARE PPE MANUFACTURERS
05
Regulatory strategy for textile & wearable products
Strategic regulatory advisory for emerging materials, technical textiles, and wearable products — from landscape mapping to certification pathway planning.
Deliverables
- Regulatory landscape mapping across US (FDA), EU (CE, REACH), and Latin American markets
- Certification pathway planning and timeline modelling
- Marketing claim substantiation and evidence package design
- Audit readiness review for ISO 9001, 13485, 17025, GMP
- Submission strategy for 510(k) and equivalent international filings
Credibility
Drove the full certification stack at Biophilica (USDA Biobased, OEKOTEX, B-Corp, ISO 9001). Championed 510(k) FDA application and ANMAT / GCMP certification processes at Kovac. Lean Six Sigma Black Belt; ISO 13485 Internal Auditor.
For: EMERGING MATERIALS COMPANIES · WEARABLES STARTUPS · SUSTAINABILITY CLAIMS TEAMS
06
Industry analysis & expert content
Research-driven analysis and expert content for the textiles, materials, and apparel industries. Independent, technical, with industry sources.
Deliverables
- Industry reports and trend analysis
- Expert interviews and Q&A pieces
- Technical articles for trade publications
- Conference and panel moderation
- Brand thought-leadership content (white papers, executive briefings)
Credibility
Published industry analysis on antimicrobials, leather alternatives, sportswear circularity, adaptive clothing, footwear componentry, and biobased aerogels. Keynote at Innovate: China in Keqiao (October 2024); guest lecturer at Nottingham Trent School of Art and Design.
For: TRADE PUBLICATIONS · INDUSTRY RESEARCH FIRMS · BRAND THOUGHT-LEADERSHIP TEAMS