Histopathology CRO · GLP · ISO/IEC 17025 accredited

From specimen to submission.

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.

GLP, Good Laboratory Practice DAkkS accredited · D-PL-22207-02-01 DAkkS Accredited · GLP Certified
Bone and cartilage section Movat pentachrome, bone integration Picrosirius red, collagen TRAP, osteoclast activity
Herovici 40× LIVE
20 µm
Bone & cartilage interface Endochondral remodelling at an implant margin.
100×

Track Record

150+Publications
8,000+Citations
25+Years' Experience
Top 5%, Histological Processing Proficiency Testing

Our Scope

A single thread through every stage

From grant-funded feasibility through post-market surveillance. Select any stage for details.

One laboratory. One quality standard. Every stage covered.

The Mechanical Spectrum

Ocular to arthroplasty, in one lab.

From soft to hard tissue, every probe processed under a single quality system.

Soft TissueParaffin embedding Hard TissueResin embedding: bone, ceramics & titanium implants
Sclera · corneaOcular Skin · nerveSoft tissue Stents · valvesCardiovascular Drug-elutingCombination ImplantsDental Hip · knee · spineArthroplastyTitanium · cobalt-chrome

Diamond saw cutting

±100 µm precision

Vacuum / pressure infiltration

60 °C · resin-grade

PMMA embedding & grinding

Hard-tissue plane

Microtome 3–10 µm

Paraffin & resin

Probes Hard, soft & combination tissue
Accreditation ISO/IEC 17025 accredited QM · GLP-aligned workflows
Workflow Single chain of custody

Services

Five disciplines, one laboratory.

Enabling research, biopsy & slide preparation, conventional staining & IHC, extensive analysis, and in-depth product classification & scientific reporting, working together around a single project.

Berlin AnalytixView research

Grants & Funding NEW

Funding support for innovators

We assist early-stage biomaterial and medical device companies in securing EU and national grant funding for preclinical validation studies.

Discuss your study

About

Why partner with BerlinAnalytix

A specialist histopathology CRO for biocompatibility evaluation under ISO 10993-6, deep scientific expertise meets the regulatory rigour that submission dossiers demand.

The Process

The journey from enquiry to submission

A structured four-phase engagement. Each stop adds accreditation-backed rigour to your regulatory dossier.

Client Voices

What our clients say

Real outcomes from our scientific partnerships.

Grants & feasibility

“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.”

Heiner KrussCEO, Xoto Technology GmbH
Allograft histomorphometry

“BerlinAnalytix quantified new bone formation and material remodelling in our processed allograft bone with exceptional precision, rigorous, reproducible, and delivered exactly to specification.”

Andreas KoglerCEO, Cells + Tissue Bank Austria (C+TBA)
Clinical biopsy study

“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.”

Dr. Tadas KorzinskasSenior Attending Physician, Charité – Universitätsmedizin Berlin
PMS combination study

“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.”

Prof. Xin XiongNMI Naturwissenschaftliches und Medizinisches Institut

Your Team

Your research partners

Every client works directly with the scientist evaluating their samples.

Research

Scientific publications

Prof. Dr. Mike Barbeck has authored 150+ publications across 20 years of peer-reviewed research, covering biocompatibility, foreign body response, biomaterial characterisation and regulatory methodology.

Browse All Publications

2026

Granulocytes and their Involvement in the Foreign Body Response to Biomaterials and Tissue Repair.

Barbeck M, Jung O · In Vivo 40(1)

2026

Biologic Functionalization of a Biphasic Bone Substitute With Enamel Matrix Derivative.

Korzinskas T, Stojanovic S, et al. · In Vivo 40(2)

2025

Validation of the Chick Chorioallantoic Membrane Model for Biocompatibility Analysis.

Barbeck M, et al. · In Vivo 39(3)

10993 Network

Full ISO 10993 coverage

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.

Select a capability to view details
In-house at BerlinAnalytix Partner lab

Need the full ISO 10993 battery?

Provide your device classification, we scope the complete testing programme across in-house and partner labs.

Scope Your Testing Programme

Ready to discuss your biocompatibility study?

We typically respond within one business day with study scoping questions, followed by a full proposal within five working days.