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The Gemarmed Consulting Team

We are quality Assurance and regulatory professionals who, from the heart, are passionate about developing medical devices, Quality Assurance and Regulatory Dossiers and have years of experience in this field. We have participated in countless audits, as auditees as well as a companion for companies. With us, you can discuss the latest technologies, Quality Assurance and Regulatory Requirements as well as the automation of your test process.
We have a very good understanding of medicine and medical terminology. We are experts in this area because we mainly operate in the healthcare industry, which is our main focus. With this specific knowledge, we can also carry out risk analyses and provide the interface for clinical testing.

Team

Dr. Mario Gennari

Dr. Mario Gennari

Company Founder, European Associate Director and Practice Leader Regulatory and Quality Consulting

European Associate Director, Practice Leader Regulatory, Quality and GMP

Experienced regulatory and quality based professional, working in the Medical Device, In-Vitro Diagnostic and Pharmaceutical Industries for over twenty years. His core expertise is in the Regulatory Requirements and Quality Management System, including Design Control, Process validation, Tests Methods Validation, Management experience in sterilization technologies and their validations clinical investigations/evaluation, PMCF in compliance with MDCG, ICH GCP and FDA guidelines and audits at sites of investigational products, clinical analysis labs. In addition, he has specific expertise in R&D and quality requirements for Medical Devices, Diagnostics and Combination products. This has included the writing, implementation and maintenance of Quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing. He also has extensive experience in the application of Design Control and post market surveillance systems for Complaints Management and Vigilance Reporting, Process Validation, CAPA, risk management and Clinical studies.

Location: Modena – Italy

European Associate Consultant, Practice Leader Regulatory, Quality and Regulatory

Giulia has experience in Quality Operations management with several domestic and international companies, working in the biotech business areas for non-active medical devices.
Management experience in Design Control, Process Validation, Tests Methods Validations, Clinical Evaluation, Biological Evaluation, R&D, in the areas of Design Quality Assurance, Design Control, Change Control, Test Protocols and Reports, Design Qualification and Validation, Product International Standards, Risk Management. R&D and Regulatory Affairs Dept. During the career, Giulia has acquired operational, strategic and organizational skills to manage processes coordinator of activities for medical devices class I-II-III:
– Product registrations in Europe
– Development of regulatory strategies and implementation plans for the preparation and submission of new products
– Post market surveillance and complaint handling at the interface with the competent authorities worldwide
– Remediation plans for non-conformities, post marketing vigilance and products recall management worldwide
– Design History Files and CE-Mark Technical Files

Focus & core competences / capacity
– Quality Management Systems implementation for ISO 13485 Certification
– Preparation and submission of Design Dossier for CE Mark, Technical Files and FDA 510(k) clearances
– Regulatory gap analysis and related risk assessments
– Design Control / Design Validation and Verification

Functional/Technical Skills
– Appliance of ISO 13485 and FDA 21 CFR820
– Ensure compliance with the European Regulations MDR 2017/745, IVDR 2017/746

Location: Modena – Italy

Dr. Giulia Orlandi

Dr. Giulia Orlandi

European Associate Consultant and Medical, Regulatory and Quality and GMP Consulting
Dr. Giovanni De Paolini

Dr. Giovanni De Paolini

European Associate Director and Practice Leader Regulatory and Quality and GMP Consulting

European Associate Director, Practice Leader Regulatory, Quality and GMP

ifteen years’ industry experience in Quality Assurance and Regulatory Affairs. Knowledge of US FDA and European Regulatory regulations. Technical files and 510(K) writing for Medical Devices, Developing Regulatory Strategies for assessment in Italian and International markets (United States 510k, Japan, China, Brasil, Mexico, Middle East, Europe), Quality System SOP review and management for obtaining and maintaining Quality System Certifications ISO13485 and US FDA GMP, Market Access Development Strategy and Action for specific countries or regions (United States, Japan, China, Brasil, Mexico, Middle East, Europe).
Developing Regulatory Strategies for regulatory approvals for medical devices in Italian and International markets (United States 510k, Japan, China, Brasil, Mexico, Middle East, Europe). Product technical documentation review and management towards CE Marking; Definition of Quality Systems and management for obtaining and maintaining Quality System Certifications ISO 13485 and US FDA GMP; Market Access Development Strategy and Action for specific countries or regions.
Product technical Documentation Review and Management, Product technical documentation review and management towards CE Marking. During the career, Giovanni has acquired operational, strategic and organizational skills to manage processes coordinator of activities for medical devices class I-II-III:
– Many product registrations worldwide
– Development of regulatory strategies and implementation plans for the preparation and submission of new products
– Post market surveillance and complaint handling at the interface with the competent authorities worldwide
– Remediation plans for non-conformities and products recall management worldwide
– Design and CE-Mark transfer to buyers and distributors for new labelling

European Associate Consultant, Practice Leader Regulatory, Quality and GMP

Silvia has experience in Quality Operations management with several domestic and international companies, working in the biotech business areas for non-active medical devices.
Management experience in sterilization technologies and their validations, Clinical Evaluation, Biological Evaluation, R&D, in the areas of Design Quality Assurance, Design Control, Change Control, Test Protocols and Reports, Design Qualification and Validation, Product International Standards, Risk Management. R&D and Regulatory Affairs Dept. Management experience in physical, chemical and toxicological evaluation, Biological Evaluation Plan and Reports, R&D, in the areas of Design Quality Assurance, Design Control, Change Control, Test Protocols and Reports, Design Qualification and Validation, Product International Standards, Risk Management. R&D Dept. and Regulatory Affairs Dept.
During the career, Silvia has acquired operational, strategic and organizational skills to manage processes and human resources to build and maintain a QMS in compliance with the cGXP requirements, according to FDA and EMA environment.

Focus & core competences / capacity
– Quality Management Systems implementation for ISO 13485 Certification
– Preparation and submission of Design Dossier for CE Mark, Technical Files and FDA 510(k) clearances
– Regulatory gap analysis and related risk assessments
– Appliance of ISO 13485 and FDA 21 CFR820
– Ensure compliance with the European Regulations MDR 2017/745, IVDR 2017/746

Location: Modena – Italy

Dr. Silvia Fantoni

Dr. Silvia Fantoni

European Associate Consultant Regulatory and Quality and GMP Consulting
Glen Feye

Glen Feye

MS- Immunopathology CQE-Certified Quality Engineer, Lead QSR and ISO 13485Auditor, FDA US Agent

MS- Immunopathology CQE-Certified Quality Engineer, Lead QSR and ISO 13485Auditor, FDA US Agent

Glen has over 20 years of FDA consulting experience helping domestic and international clients overcome various FDA compliance challenges. He has assisted clients with FDA inspections and successfully mitigated over 25 Warning Letters. Mr. Feye has also authored and managed numerous regulatory submissions for device, IVD, biologic, pharmaceutical, and combination products

Glen is an expert in quality systems. He has help implement numerous efficient and effective quality management systems for various medical devices, IVD and pharmaceutical companies.
– Design Controls and Risk Management- Biocompatibility and Sterilization
– Complaint handling including post market surveillance remediation including MDR, and Corrections and Removals
– QMS Auditor, development of quality system improvement plans to address system gaps and non-conformities

Location: San Diego, CA

European Associate Director – and Practice Leader GMP, Process and SW validation

Graduated in Chemistry and Pharmaceuticals Technologies, since 2002 Simone has been working in the Pharmaceutical and Medical Devices fields, like consultant, in the mayor biotech companies producing Sterile and Not Sterile products. The professional career evolved in growing responsibilities, managing projects with relevant complexity in the Quality, Auditing and Validation.
As Lead Auditor, Simone carrys out supplier audits against QMS (based on ISO 9001:2015) and cGMP (based on ICH 7 for APIs) requirements for a variety of European and US pharmaceutical, medical device, and chemical companies. The main expertise is addressed on:

– Quality Assurance/Compliance/Validation
– Computer System Validation
– Lean & OPEX
– FDA and AIFA inspections
– Auditing (ICH, ISO 13485, Eudralex Vol 4, 21 CFR 210, 211);
– Project Management;
– Business Development

Dr. Simone Guerrieri

Dr. Simone Guerrieri

European Associate Director - and Practice Leader GMP, Process and SW validation
Mauzia Corazzari

Mauzia Corazzari

European Associate Consultant, Practice Leader Regulatory, Quality and GMP

Dr. Mauzia Corazzari European Associate Consultant, Practice Leader Regulatory, Quality and GMP

Mauzia has experience in Design Control, Regulatory Affairs and Quality Operations management with several domestic and international companies, working in the biotech business areas for non-active medical devices.
Management experience in Design Control, Clinical Evaluation, Biological Evaluation, R&D, in the areas of Design Quality Assurance, Design Control, Change Control, Test Protocols and Reports, Design Qualification and Validation, Product International Standards, Risk Management. R&D and Regulatory Affairs Dept. During the career, Giulia has acquired operational, strategic and organizational skills to manage processes coordinator of activities for medical devices class I-II-III:
Product registrations in Europe
Development of regulatory strategies and implementation plans for the preparation and submission of new products
Design History Files and CE-Mark Technical Documentation.
Focus & core competences / capacity
Quality Management Systems implementation for ISO 13485 Certification
Preparation od Design History Files, V&V strategy and test protocols, Risk Management File, Document Controls.
Preparation and submission of Technical Documentation for CE Mark, FDA 510(k) clearances
Regulatory gap analysis and related risk assessments
Design Control / Design Validation and Verification
Functional/Technical Skills
Appliance of ISO 13485 and FDA 21 CFR820
Ensure compliance with the European Medical Device Regulations MDR 2017/745, IVDR 2017/746

Location: Mantova – Italy

Regulatory Affairs Consultant, BSC

Sebastian is a Regulatory Affairs specialist and project manager for both medical device, IVD and drug projects. He communicates directly with FDA and serves as the liaison between clients and FDA. Sebastian has prepared and submitted successful EUA, Pre-Submissions, 510k, and IDE submissions for development of new medical devices. Sebastian also serves as project manager for various non-compliance projects, including 483 and Warning letter remediation projects, Additionally, he manages FDA device and drug registration and listing for both domestic and international clients.

Location: San Diego, CA

Sebastian Feye

Sebastian Feye

Regulatory Affairs Consultant, BSC