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ISO 10993 Specialist · EU MDR · FDA

Scientifically
Defensible
Biocompatibility
Documentation

I help medical device companies prepare ISO 10993 biological evaluation documentation — BEP, BER, and TRA — that satisfies notified body and FDA reviewers. Real science. Not templated reports.

Free 15-Min Consultation View Services
BEP in 3–5 days
BER in 5–7 days
1 revision included

ISO 10993 Expert

Biocompatibility Consultant

10+
100+
3 Days
Biological Evaluation Plan
Biological Evaluation Report
Toxicological Risk Assessment
Gap Analysis ISO 10993-1:2025
IIT Kanpur MTech · IIT Kanpur
Marie Curie Fellow · INSERM
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Expertise across global regulatory frameworks

ISO 10993-1:2025
EU MDR 2017/745
FDA 510(k)
ISO 10993-5 Cytotoxicity
ISO 10993-17/18 TRA
ISO 13485 / ISO 14971
Device Categories

Devices I Work With

If your device touches, implants into, or communicates with the human body — I can prepare the biological evaluation documentation.

Implantable Devices

Long-term and permanent implants — the most demanding biocompatibility category requiring full endpoint coverage and genotoxicity assessment.

BiosensorsBone screwsCardiac implantsNeural probes

Wound Care & Dressings

Surface-contacting devices with intact or compromised skin contact. Biocompatibility assessment for wound care materials and dressings.

Wound dressingsHydrogelsHemostatic agents

Catheters & Tubing

Short and long-term blood/tissue contact devices. Chemical characterization, extractables assessment, and TRA for polymeric materials.

IV cathetersUrinary cathetersDrainage tubing

Dental Devices

Oral contact devices including restorative materials, surgical instruments, and orthodontic devices requiring ISO 10993 biological evaluation.

Dental implantsRestorative materialsOrthodontics

Cardiovascular Devices

Blood-contacting devices with critical biocompatibility requirements including thrombogenicity and haemocompatibility endpoint evaluation.

StentsHeart valvesVascular grafts

Diagnostic & IVD-Adjacent

Devices that contact the patient during diagnostic procedures — biosensors, imaging probes, and electrochemical sensors.

Glucose sensorsECG electrodesImaging devices

Orthopaedic Devices

Bone-contacting implants and fixation devices requiring genotoxicity, implantation, and systemic toxicity endpoint evaluation.

Joint replacementsFixation platesBone cements

Ophthalmic Devices

Devices in contact with ocular tissue — a sensitive contact category requiring careful material selection and cytotoxicity evaluation.

Contact lensesIntraocular lensesSurgical tools

Not sure if your device fits? Send me a brief description — I'll confirm scope and timeline within 24 hours, no obligation.

The Challenge

Common ISO 10993 Problems I Solve

Medical device companies face recurring biological evaluation challenges. I specialize in resolving each one.

Notified Body Query on BEP/BER

Your notified body flagged gaps in your biological evaluation plan or report. I prepare structured, scientifically justified responses.

BEP/BER Gap Resolution

Uncertain Which Tests to Waive

ISO 10993-1 allows test waivers with proper justification. I identify which endpoints can be justified and prepare the scientific rationale.

Test Waiver Justification

First Biocompatibility Assessment

MedTech startups preparing their first biological evaluation documentation. I build scientifically defensible BEPs from scratch.

Full BEP Development

FDA 510(k) Section Rejected

Your biocompatibility section was rejected or flagged by FDA. I prepare FDA-aligned documentation per the 2020 ISO 10993 guidance.

FDA Section Remediation

Material or Design Change

Device material or design change triggers a biocompatibility re-evaluation. I perform change impact assessments aligned with ISO 10993-1.

Change Impact Assessment

Legacy BER Needs Update

ISO 10993-1:2025 introduced lifecycle approach changes. I perform gap analysis and update legacy documentation to current requirements.

ISO 10993-1:2025 Upgrade
What I Deliver

ISO 10993 & Regulatory Services

Comprehensive biological evaluation and regulatory documentation services for medical device submissions.

Biological Evaluation Plan (BEP)

ISO 10993-1:2018/2025 compliant endpoint strategy. Delivered in 3–5 business days.

ISO 10993-1:2025

Biological Evaluation Report (BER)

Literature evaluation, existing data assessment, risk-based conclusions. 5–7 business days.

ISO 10993-1:2025

Toxicological Risk Assessment (TRA)

AET/TTC calculations per ISO 10993-17 and ISO 10993-18 for extractables and leachables.

ISO 10993-17/18

ISO 10993-1:2025 Gap Analysis

Assess existing BEP/BER documentation against the updated 2025 requirements. Identify and resolve gaps.

2025 Update

Biocompatibility Documentation Review

Expert audit of your documentation before notified body or FDA submission to identify issues proactively.

Pre-submission

EU MDR Technical File — Biocompatibility Section

Annex I GSPR §10 compliant documentation for CE Mark technical file submission.

EU MDR

FDA 510(k) Biocompatibility Section

Per FDA ISO 10993 guidance (2020). Structured biocompatibility summary aligned to FDA reviewer expectations.

FDA 510(k)

Clinical Evaluation Report (CER)

MEDDEV 2.7/1 Rev.4 compliant clinical evaluation reports for EU MDR CE Mark submissions.

EU MDR

Post-Market Surveillance (PMS & PMCF)

PMCF Plan and Report documentation plus PMS documentation aligned to EU MDR requirements.

Post-Market

Peer-Reviewed Manuscript Preparation

Scientific manuscript writing and editing for biomedical journals. Published in Bioelectrochemistry (Elsevier) and Advanced Sensor Research (Wiley).

Publication

Systematic Literature Reviews

PRISMA-structured systematic literature reviews for biological evaluation and clinical evaluation reports.

PRISMA

White Papers & Technical Reports

White papers, technical summaries, and grant proposals for MedTech R&D and regulatory strategy.

Technical Writing
View All Services
Why MedTechISO

Real Biocompatibility Science, Not Template Writing

I have personally conducted cytotoxicity assays, studied inflammatory responses to biomaterials, and published research on biological evaluation endpoints. With 10+ years in biomaterials science and hands-on bench experience, when I write your BER, I understand the science behind each endpoint — not just the regulatory requirement.

Bench-Level Research Experience

Hands-on cytotoxicity, oxidative stress, and biomaterial–cell interaction research at INSERM U1026 Biotis, Bordeaux, France under Marie Skłodowska-Curie Fellowship (Horizon 2020).

ISO 10993-1:2025 Expert

Deep knowledge of the 2025 revision — lifecycle approach, explicit benefit-risk determination, test waiver justification, and legacy BEP/BER gap analysis. I build documentation that passes first review.

Implantable Device Specialist

PhD research on implantable electrochemical biosensors at IIT Kanpur — covering the most demanding biocompatibility category: long-term implant contact, genotoxicity, and chronic toxicity pathways.

Fast, Structured Delivery

BEP in 3–5 business days. BER in 5–7 business days. Delivered in Word and PDF with one revision included. Available across EU, US, and Asia-Pacific time zones.

Nationally Recognised & Certified

GATE qualified (top national engineering exam, India). AICTE National Doctoral Fellowship recipient. Animal cell culture certified — CCMB, Hyderabad. Upwork Verified & ID Verified.

About Arvind
Arvind Rathore

Arvind Rathore

ISO 10993 Biocompatibility Consultant

Kanpur, India
MTech — Biological Sciences & Bioengineering Indian Institute of Technology Kanpur (IIT Kanpur)
Marie Skłodowska-Curie Early Stage Researcher INSERM U1026 Biotis, Bordeaux, France · Horizon 2020
Published Researcher Bioelectrochemistry (Elsevier, 2025) · Advanced Sensor Research (Wiley, 2024)
Founder — MedTechISO ISO 10993 consulting and educational platform
ISO 10993 Parts 1, 5, 10, 17, 18 2018 & 2025 revisions · EU MDR · FDA guidance 2020
Animal Cell Culture Certified CCMB, Hyderabad · ISO 13485 & ISO 14971 expertise
GATE Qualified · AICTE NDF Recipient National engineering exam topper · National Doctoral Fellowship
PhD — Biological Sciences & Bioengineering IIT Kanpur · Implantable electrochemical biosensors
$55/hr Upwork Verified · ID Verified
English Fluent
Hindi Native
French Basic
Available Mon–Sat · EU, US & APAC time zones
How It Works

From Inquiry to Delivered Documentation

A clear, structured process from first contact to submission-ready documentation.

01

Free 15-Min Call

We discuss your device, material, contact category, and submission timeline. No obligation. I respond within 24 hours.

02

Scope & Proposal

I define the documentation scope, endpoint strategy, and deliverables. Clear timeline and fixed price quote.

03

Documentation Drafting

I prepare scientifically grounded BEP/BER/TRA documentation aligned to your regulatory target (EU MDR or FDA).

04

Review & Delivery

You review the draft, provide feedback, and I finalize. Delivered in Word and PDF. One revision included.

10+
3-5 days
5-7 days
2 Publications
Project Outcomes

Recent Client Projects

Anonymized project outcomes across device types and regulatory pathways. Specific details withheld under client confidentiality.

BEP + BER EU MDR

Implantable Biosensor — CE Mark Submission

Electrochemical glucose sensor for long-term subcutaneous implantation. Prepared full BEP and BER covering 14 ISO 10993 endpoints including genotoxicity and chronic toxicity. Notified body accepted documentation without additional information request.

Delivered in 6 days
First-review acceptance
Long-term implant category
FDA Remediation FDA 510(k)

Vascular Catheter — FDA Additional Information Response

FDA issued an additional information request citing incomplete cytotoxicity extract rationale and missing chemical characterization for the polymeric hub. Prepared targeted response document with AET calculations and test waiver justifications. 510(k) clearance received.

Response in 4 days
510(k) cleared
Blood-contacting device
Gap Analysis ISO 10993-1:2025

Wound Dressing — Legacy BER Gap Analysis

MedTech startup with an existing BER prepared under ISO 10993-1:2018. Performed gap analysis against the 2025 revision requirements. Identified 3 documentation gaps including missing benefit-risk determination language and lifecycle approach framing. Updated BER sections delivered.

Analysis in 3 days
3 gaps resolved
Surface contact device
TRA EU MDR

Orthopaedic Fixation Device — Toxicological Risk Assessment

Titanium-alloy bone fixation plate with polymeric coating. Performed ISO 10993-17/18 compliant TRA including chemical characterization of coating extractables, AET thresholds, and TTC-based waiver justification for three compounds below detection limits.

TRA in 5 days
3 test waivers justified
Bone-contacting implant
Full Technical File Section EU MDR

Dental Implant — EU MDR Technical File Biocompatibility Section

First-time EU MDR submission for a zirconia dental implant. Drafted the complete Annex I GSPR §10 biocompatibility section including BEP, BER, and risk management integration. Notified body confirmed documentation was complete at initial technical review.

Full section in 7 days
No NB queries raised
First EU MDR submission
Change Assessment FDA 510(k)

Catheter Hub Material Change — Re-evaluation Assessment

Manufacturer changed hub material from ABS to a medical-grade polycarbonate blend. Performed ISO 10993-1:2025 change impact assessment, documented chemical equivalence rationale, and confirmed no new testing required. Updated BER section ready for 510(k) amendment filing.

Assessment in 3 days
No new testing needed
Material change re-eval

All project details are anonymized. Client identities, company names, and device-specific data are kept strictly confidential.

Regulatory Expertise

Frameworks & Standards I Work With

ISO 10993

Biological Evaluation Series

  • Part 1: Evaluation & Testing (2018 & 2025)
  • Part 5: Cytotoxicity
  • Part 10: Sensitization & Irritation
  • Part 17: Toxicological Risk Assessment
  • Part 18: Chemical Characterization
EU MDR

EU MDR 2017/745

  • Annex I — GSPR §10 Biocompatibility
  • Annex II — Technical Documentation
  • Annex III — PMS Documentation
  • CER (MEDDEV 2.7/1 Rev.4)
  • PMCF Plan & Report
FDA

FDA 510(k) & PMA

  • FDA ISO 10993 Guidance (2020)
  • 510(k) Biocompatibility Section
  • De Novo Submissions
  • PMA Applications
  • FDA Query Responses
QMS / RM

Quality & Risk Management

  • ISO 13485:2016 QMS
  • ISO 14971:2019 Risk Management
  • Risk-Based Biocompatibility Strategy
  • Design Control Documentation
  • CAPA Documentation
Get Started

How to Hire Me

Three clear engagement paths. Pick the one that matches your situation — or contact me and I'll recommend the right scope.

Option 01

Documentation Review

You have existing BEP / BER / TRA — you need an expert check before submission

  • Expert review of your existing BEP, BER, or TRA
  • Written gap report with specific findings
  • Recommended fixes per ISO 10993-1:2025
  • Regulatory alignment check (EU MDR or FDA)
  • One follow-up call to discuss findings
Delivered in 2–3 business days
Best for: Pre-submission audit · Notified body prep · Internal QA review
Start with a Review
Most Popular
Option 02

Full Documentation Draft

You need a complete BEP, BER, or TRA written from scratch

  • Full BEP or BER drafted from device brief
  • All applicable ISO 10993 endpoints addressed
  • Scientifically justified test waivers where applicable
  • Aligned to EU MDR Annex I §10 or FDA 2020 guidance
  • Delivered in Word + PDF, one revision included
BEP: 3–5 days · BER: 5–7 days
Best for: First submission · New device · Material change · Startup CE/FDA filing
Start Full Documentation
Option 03

Deficiency Remediation

FDA or notified body flagged your documentation — you need a targeted, fast response

  • Analysis of FDA/NB deficiency letter or query
  • Point-by-point written response document
  • Updated BEP/BER sections where required
  • Scientific justification for each deficiency
  • Submission-ready format, one revision included
Delivered in 3–5 business days
Best for: FDA AI request · NB query response · 510(k) remediation
Start Remediation
Not sure which option fits?

Book a free 15-minute call. I'll listen to your situation and tell you exactly what scope is needed — no upselling, no obligation.

Book Free Call
Regulatory Blog

Latest Insights

Expert articles on ISO 10993, EU MDR and FDA biocompatibility — written by a practising consultant, not a template library.

View All 12 Articles
Ready to Start?

Preparing a Biological Evaluation?
Let's Talk.

Whether you're preparing an initial BEP, responding to a notified body query, or updating legacy documentation to ISO 10993-1:2025 — I offer a free 15-minute introductory call to understand your project before any engagement.

Book Free 15-Min Call arvindrthr0607@gmail.com

I respond within 24 hours on business days