Medical Device Training Courses Overview

Our robust medical device training courses are designed to help employees in various roles improve day-to-day productivity.

Benefits of our Medical Device Training Courses

Medical device coursework is developed and administered by industry-active instructors—satisfying specific disciplines and enhancing cross-discipline exposure. Medical device training program attendees benefit from lively discussions with peers in an open, interactive setting. The discussion of real-world experiences amongst the instructor and participants allows for expanded viewpoints that can benefit employees daily.

Our medical device training and medical device quality assurance certification courses allow you to:

Meet the challenges of expanding regulations.
Understand demands for cutting-edge technology with proven value and constant advances in medical procedures.
Gain knowledge applicable from device design through servicing.
Fill the growing gap between talent and development needs.

Medical Device Training Include:

Best practices
Clinical trials
Design control principles
Document management
FDA regulatory compliance
Process validation
Qualifying suppliers
Quality principles

Advanced Topics in Biostatistics for Non-Statistician Auditing and Qualifying Suppliers and Vendor Best Practices for an Effective Cleaning Validation Program Biostatistics for Non-Statistician Cleanroom Fundamentals: Regulation, Science, Design, Practice, Operation and Management European Regulatory Procedures - EMA and National Requirement Clinical Document Management: A Trial-by-Trial Compliance Approach Clinical Trial Project Management, Phase 1-4 Best Practices Computer System Validation US Medical Device Law & FDA Design Controls Essentials US Medical Device Regulations - Design Verification Validation & Risk Analysis Effective Document Management for Pharma, Biotech & Medical Device Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries

European Union Regulatory Issues – New Product Development FDA Inspections: What Regulators Expect and How to Prepare GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trial Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirement Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies Good Manufacturing Practices Training | GMP Course Integration of Risk Management Principles and Activities into the Quality System Introduction to Medical Combination Product Introduction to Medical Device Submissions - 510ks, PMAs, and Exemptions Introduction to Statistical Analysis of Laboratory Data Laboratory Equipment Validation and Qualification Marketing & Advertising of Pharmaceutical & Medical Device

Medical Device Process Validation Training for Professionals Medical Devices - Developing Effective Post Market Surveillance and Complaint Handling Systems Medical Devices: The New MDRs, EU Directives, Guidance, CE Marking and ISO Standard Certifications Overview of FDA Regulatory Compliance for Medical Devices QbD: Product and Process Optimization using Design of Experiments Selecting and Managing CRO Technical Writing for Pharma, Biotech and Med Device Understanding & Implementing the New EU Clinical Trial Regulation & GDPR US Medical Device Law & FDA Design Controls Essentials US Medical Device Regulations - Design Verification Validation & Risk Analysis Writing Effective Monitoring Reports and Good Documentation Practices: A Symbiotic Relationship Writing Effective SOP and Other Process Documents

Advanced Topics in Biostatistics for Non-Statistician Auditing and Qualifying Suppliers and Vendor Best Practices for an Effective Cleaning Validation Program Biostatistics for Non-Statistician Cleanroom Fundamentals: Regulation, Science, Design, Practice, Operation and Management European Regulatory Procedures - EMA and National Requirement Clinical Document Management: A Trial-by-Trial Compliance Approach Clinical Trial Project Management, Phase 1-4 Best Practices Computer System Validation Effective Document Management for Pharma, Biotech & Medical Device Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries

FDA Inspections: What Regulators Expect and How to Prepare GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trial Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirement Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies Good Manufacturing Practices Training | GMP Course Integration of Risk Management Principles and Activities into the Quality System Intro to Medical Device Submission - 510(k)s, PMAs, & Exemptions Introduction to Medical Combination Product Introduction to Statistical Analysis of Laboratory Data Laboratory Equipment Validation and Qualification Marketing & Advertising of Pharmaceutical & Medical Device

Medical Device Process Validation Training for Professionals Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals Overview of FDA Regulatory Compliance for Medical Devices QbD: Product and Process Optimization using Design of Experiments Selecting and Managing CRO Technical Writing for Pharma, Biotech and Med Device Understanding & Implementing the New EU Clinical Trial Regulation & GDPR US Medical Device & Quality System Regulations - Design Controls & Validation Writing Effective SOP and Other Process Documents

Medical Device Customized On-Site Training

Many of our medical device training courses can also be taught at your specific company’s location. Our custom on-site training allows you and your team to access coursework in a tailored format to best suit your needs.

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Medical Device Certification

Our Certification Program has been utilized by hundreds of medical device professionals. These professional certifications are recognized by the medical device industry and can help you enhance your credibility and expand your career options. A medical device quality assurance training certification is available at no additional cost to regular courses as well.

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ABOUT US

The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site, and certification programs.

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128 Pottstown Pike
Chester Springs, PA 19425 USA

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