Medical Devices Consulting & Interim Management    Competence

Quality Management - Regulatory Affairs - Clinical Studies - Technical Documentation - Risk Management - Sterilization - Biocompatibility - Packaging - Labeling - Validation - Audits

I do have extensive knowledge of Quality Management (EN ISO 13485, ISO 9001, 21CFR Part 820, 21CFR Part 211, cGMP, GCP, 21CFR Part 4) and Regulatory Affairs (Europe, Americas, Asia). European Medical Devices Regulation (MDR). Medical Device Performance, Safety, Clinical effectiveness & usability.

As Vice President Quality Management & Regulatory Affairs, I have been working in various global medical devices companies.

Strategic and hands-on work experience include: 

Quality-Management-System Certification according to current EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes

Management of internal and external suppliers, such as required for R&D, additive manufacturing, coating, biocompatibility, mechanical & electrical testing, labeling (UDI), packaging, and sterilization.

Structuring, completion, and reorganization of Technical Files to fit global requirements have been and still are within my main focus. Such work experience includes, but is not limited to, Risk Management (EN ISO 14971, EN ISO 12100), Validation of EO-, radiation-, and steam-sterilization (EN 556, EN ISO 11135 & 11137), Clinical Evaluation (EN ISO 14155), physical-mechanical testing (EN IEC 60601), software validation (EN ISO 62304) and Biocompatibility testing (EN ISO 10993). Validation of product & production processes (DQ, IQ, OQ, PQ), including Enterprise Resource Planning (ERP) and stand-alone medical device software.

Process capability evaluation of drug-device combination products (e.g. drug release kinetics, content, purity, and surface coating condition). 

Post market surveillance activities include effective management of customer complaints, Corrective And Preventive Action (CAPA) including non-conformities (NC), medical device reports (MDR) and medical device vigilance reports (MDV) to competent authorities (e.g. US-FDA, BfArM), as well as post market clinical follow-up to obtain long-term safety & function data on medical devices form participating patients.

Reimbursement for medical devices leading to return of investments.

Customers (selection):

• Alcon 
• Artivion Inc. 
• bebro Elektronik GmbH  
• Bioimplon GmbH
• Biotronik AG 
• delta pronatura GmbH
• DePuy Synthes - J&J
• Dornier MedTech 
• Dürr Dental AG 
• Fresenius Medical Care - VIVONIK 
• Hartmann AG 
• Jostra AG   -  Getinge AB 
• Jotec GmbH
• Maquet AG -  Getinge AB
• Merck KGaA
• Novartis Alcon Grieshaber AG
• okuvision GmbH
• Osypka AG
• Pajunk GmbH
• Retina Implant AG 
• Richard Wolf GmbH
• Siemens Healthineers

www.hekmat-consulting.de