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 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
ISO 10993-21	-
ISO/TR 10993-22	Guidance on nanomaterials
ISO 10993-23	Tests for irritation
Source: www.beuth.de/en

Bioburden

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (EN ISO 11737-1)

Contact us to structure your Biocompatibility tests series, evaluate reports, and/or update your Biocompatibility files.

Dr. Hekmat CONSULTING

www.hekmat-consulting.de

Interim Management & effective Consulting

Regulatory Affairs & Quality Management, Class III Medical Devices & Combination products

25+ years of effective Strategic & Operative expertise in Clinical & Regulatory Affairs plus Quality Management for Medical Devices industry. Market Access, within the medical fields of Arterial implants, Cardiology, open Heart & Vascular Surgery, Ophthalmology, Neuro-stimulation, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, OCT, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

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

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

Certifications acc. current EN ISO 13485 Quality Management Systems,

GMP, GCP, GLP, GDP,

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

Product & Production-process Risk Management from Design to market (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