EU MDR: EU Medical Device Regulation - Chapter 6: Clinical Evaluation and Clinical Investigations
Enrollment Period: 12 months.
Average Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online, asynchronous, self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Three (3) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $199.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: EU MDR: EU Medical Device Regulation - Chapter 6: Clinical Evaluation and Clinical Investigations
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
This is a significant and exciting chapter introducing a life-cycle approach to ongoing CE Marking compliance; it is a process, not a project. One output of the clinical evaluation process is demonstrating clinical performance of the medical device, i.e. demonstrating that the device performs as intended and has benefit to patients. Clinical data in support of performance can come from many sources including: clinical literature, trials, usability, post-market clinical follow-up (PMCF), the state-of-the-art, and/or from 'equivalent' devices.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
- Previous Module
- Module Introduction
- Learning Objectives for this Module
Articles 61: 62
- Article 61: Clinical Evaluation: Part 1
- Article 61: Clinical Evaluation: Part 2
- Article 62: General Requirements Regarding Clinical Investigations Conducted to Demonstrate Conformity of Devices: Part 1
- Article 62: General Requirements Regarding Clinical Investigations Conducted to Demonstrate Conformity of Devices: Part 2
- Article 62: General Requirements Regarding Clinical Investigations Conducted to Demonstrate Conformity of Devices: Part 3
Articles 63: 69
- Article 63: Informed Consent
- Article 64: Clinical Investigations on Incapacitated Subjects
- Article 65: Clinical Investigations on Minors
- Article 66: Clinical Investigations on Pregnant or Breastfeeding Women
- Article 67: Additional National Measures
- Article 68: Clinical Investigations in Emergency Situations: Part 1
- Article 68: Clinical Investigations in Emergency Situations: Part 1
- Article 69: Damage Compensation
Articles 70 -79
- Article 70: Application for Clinical Investigations
- Article 71: Assessment by Member States
- Article 72: Conduct of a Clinical Investigation
- Article 73: Electronic System on Clinical Investigations
- Article 74: Clinical Investigations Regarding Devices Bearing the CE Marking
- Article 75: Substantial modifications to Clinical Investigations
- Article 76: Corrective measures to be taken by Member States and Information Exchange Between Member States
- Article 77: Information From the Sponsor at the End of a Clinical Investigation or in the Event of a Temporary Halt or Early - Termination: Part 1
- Article 77: Information From the Sponsor at the End of a Clinical Investigation or in the Event of a Temporary Halt or Early - Termination: Part 2
- Article 78: Coordinated Assessment Procedure for Clinical Investigations: Part 1
- Article 78: Coordinated Assessment Procedure for Clinical Investigations: Part 2
- Article 79: Review of Coordinated Assessment Procedure
Articles 80: 82
- Article 80: Recording and reporting of Adverse Events that Occur During Clinical Investigations
- Article 81: Implementing Acts
- Article 82: Requirements Regarding Other Clinical Investigations
This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR).
EU MDR: EU Medical Device Regulation - Chapter 6: Clinical Evaluation and Clinical Investigations is included in the following professional certification programs:
EU Medical Device Regulation (EU MDR) for ProfessionalsCourse ID: EUMDR
Price: $1295.00.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
Benefits of Training with Biopharma Institute
|Immediate access to courses:||Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.|
|Self-paced, asynchronous eLearning:||24/7 access to all course materials and assessments for 12 months.|
|Open enrollment:||No prior course prerequisites or work experience required.|
|Expertise:||Courses developed by subject matter experts (SMEs) in the area being taught.|
|Current and validated:||Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.|
|Optimized for learning:||Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.|
|Secure and safe access:||Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.|
|Flexible final assessments:||Multiple-choice questions can be taken repeatedly until a passing score is achieved.|
|Direct access to certificates:||Certificate of completion is instantly available once requirements have been fulfilled.|
|Verification of training:||Certificates verifiable online with digital badges issued for all professional certification programs.|
|Training manager access:||A proprietary portal offers access to download enrollment reports, training records, account balance, and more.|
|SCORM-compliant courses:||Courses can be delivered directly to most corporate Learning Management Systems (LMS).|
|Purchase orders (POs):||POs are accepted from all companies. Request an invoice when starting the procurement process.|
|Reimbursement:||Some employers may reimburse their employees for training expenses. Check your company's policy.|
|Financial assistance:||Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.|
|Career advancement:||Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.|