Biocompatibility: Biological evaluation of medical devices

 ISO 10993-1  

Evaluation and testing within a risk management system

 

 ISO 10993-2  

Animal welfare requirements

 ISO 10993-3  

Tests for genotoxicity, carcinogenicity and reproductive toxicity

 ISO 10993-4  

Selection of tests for interactions with blood

 ISO 10993-5  

Tests for in vitro cytotoxicity

 ISO 10993-6  

Tests for local effects after implantation

 ISO 10993-7  

Ethylene oxide sterilization residuals

 ISO 10993-8

Selection and qualification of reference materials for biological tests

 ISO 10993-9  

Framework for identification and quantification of potential degradation products

 ISO 10993-10  

Tests for irritation and skin sensitization

 ISO 10993-11  

Tests for systemic toxicity

 ISO 10993-12  

Sample preparation and reference materials

 ISO 10993-13  

Identification and quantification of degradation products from polymeric medical devices

 ISO 10993-14  

Identification and quantification of degradation products from ceramics

 ISO 10993-15  

Identification and quantification of degradation products from metals and alloys

 ISO 10993-16  

Toxicokinetic study design for degradation products and leachables

 ISO 10993-17  

Establishment of allowable limits for leachable substances

 ISO 10993-18  

Chemical characterization of materials

 ISO 10993-19  

Physico-chemical, morphological and topographical characterization of materials

 ISO 10993-20  

Principles and methods for immunotoxicology testing of medical devices

Source:

http://www.beuth.de/en

 

 

Contact me to structure / update your Biocompatibility files.

Consulting   & Interim Management

Quality Management & Regulatory Affairs  Medical Devices & Combination products

 

Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

Technical Documentation (DHF, DMR, DHR) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.

Compliance to applicable Standards (ISO, IEC, EN, MIL).

Manufacturing Process Verification, Validation (IQ, OQ, PQ).

Product & Production-process Risk Management (Risk Analysis & Risk Control), including Additive Manufacturing. 

Clinical Evaluation, Organization of global multicenter Clinical Studies.

Audits of Production Processes & Suppliers.

Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.

On site Support in Notified Body audits, and FDA inspections.

Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.

 

 

Dr. Hekmat CONSULTING

www.hekmat-consulting.de

 

USt-ID Nr.: DE295239280

 

Im Brühl 10/1, 72144 Dusslingen, Germany  (Stuttgart area)

Email: anusch.hekmat@gmail.com

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat

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