Histopathology CRO · GLP · ISO/IEC 17025 accredited
A specialist histopathology lab for biocompatibility, guiding your medical device or biomaterial from first feasibility study to regulatory approval and beyond, every section read under one accredited quality system.
DAkkS Accredited · GLP Certified
Track Record
Our Scope
From grant-funded feasibility through post-market surveillance. Select any stage for details.
One laboratory. One quality standard. Every stage covered.
The Mechanical Spectrum
From soft to hard tissue, every probe processed under a single quality system.
±100 µm precision
60 °C · resin-grade
Hard-tissue plane
Paraffin & resin
Services
Enabling research, biopsy & slide preparation, conventional staining & IHC, extensive analysis, and in-depth product classification & scientific reporting, working together around a single project.
View research Grants & Funding NEW
We assist early-stage biomaterial and medical device companies in securing EU and national grant funding for preclinical validation studies.
About
A specialist histopathology CRO for biocompatibility evaluation under ISO 10993-6, deep scientific expertise meets the regulatory rigour that submission dossiers demand.
The Process
A structured four-phase engagement. Each stop adds accreditation-backed rigour to your regulatory dossier.
Client Voices
Real outcomes from our scientific partnerships.
“BerlinAnalytix was instrumental in securing funding for our wound-monitoring project, and the in vivo wound model study delivered excellent results for our camera system. A competent and dependable partner for grant consulting and preclinical feasibility.”
“BerlinAnalytix quantified new bone formation and material remodelling in our processed allograft bone with exceptional precision, rigorous, reproducible, and delivered exactly to specification.”
“Through histological investigation of biopsies from my own patients, we determined which regenerative materials achieve the best long-term integration and healing, data that has directly refined my clinical practice.”
“Our most recent project paired biocompatibility evaluation with detailed material composition and trace analysis for a PMS study. From study design through reporting, the collaboration was seamless.”
Your Team
Every client works directly with the scientist evaluating their samples.
Chief Executive Officer · Founder
Co-founder and Principal Investigator, 150+ peer-reviewed publications on biocompatibility and the foreign-body response.
Lab Leader · Head of Business Development
Runs the GLP test facility and works directly with sponsors on study design and regulatory reporting.
Scientific Investigator
Leads histological assessment under ISO 10993-6, soft and hard tissue, scoring and interpretation.
Quality Management Officer
Keeps the ISO/IEC 17025 accreditation and GLP certification upheld in day-to-day operations.
10993 Network
One point of contact. Our accredited partner network covers every test in the ISO 10993 battery, histopathology and histomorphometry in-house, surrounding capabilities via vetted partner labs.
Provide your device classification, we scope the complete testing programme across in-house and partner labs.
Scope Your Testing ProgrammeWe typically respond within one business day with study scoping questions, followed by a full proposal within five working days.
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