The course begins by focusing on quality management specifically for the manufacture of medical devices. In accordance with the Medical Device Regulation (MDR), every company manufacturing in this sector must establish, document, and manage a risk management system to ensure the safety of its products. The course covers all relevant knowledge and applicable standards. Later in the course, you’ll learn about statistics and the commonly used methods for verifying observations and interpreting measurement data. To support this, you’ll learn how to use statistical software and receive an introduction to experimental design.
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Certificates: Certificate "Quality management in the medical device industry"
Certificate "Statistics and data analysis" -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
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Teaching Times: Full-timeMonday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
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Language of Instruction: German
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Duration: 8 Weeks
QM in the medical device industry
Introduction to General Quality Management (approx. 0.5 days)
Fundamentals of QM
Quality Methods and Quality Tools
Artificial intelligence (AI) in the work process (approx. 0.5 days)
Document review with AI support
Regulatory requirements (AI Act)
Regulatory Framework and Approval of Medical Devices (approx. 1.5 days)
MDR and IVDR
Classification and Conformity Assessment Procedures
Economic operators, notified bodies, and regulatory responsibilities
UDI and Product Registration in EUDAMED
Special Considerations for Software as a Medical Device (Classification, Key Principles of IEC 62304)
Structure and Components of the Technical Documentation
QM – Medical Devices ISO 13485 (approx. 1.5 days)
Structure, Scope, and Application of ISO 13485
Relationship Between MDR/IVDR and ISO 13485
Design and Development Control, Verification, and Validation
ISO 13485 and the FDA Quality Management System Regulation (QMSR/21 CFR Part 820)
Risk Management (approx. 2 days)
Significance of the ISO 14971 Risk Management Standard
Risk Analysis, Risk Assessment, and Risk Control
Risk Management Throughout the Product Life Cycle
Requirements for Management Systems (approx. 2.5 days)
ISO 9001 vs. ISO 13485
Responsibilities, Resources, and Competence Management
Measurement and Test Equipment Management for Medical Devices and Diagnostics
Test Planning and Fundamentals of Statistical Sampling Methods (AQL)
Process-Oriented Quality Management (approx. 2 days)
Importance of processes, process orientation, process description, and process validation
Corrective and Preventive Actions (CAPA Process)
Continuous Improvement Process (CIP)
Fundamentals of Change Control for Approved Products
Documentation Systems (approx. 3 days)
Fundamentals of general QM documentation, document control, and archiving
Validation Parameters (IQ, OQ, PQ)
Technical Documentation According to MDR/IVDR
Fundamentals of Supplier Management (Supplier Qualification, Supplier Audits)
Fundamentals of clinical evaluation and the Clinical Evaluation Report (CER)
Interface Between Clinical Evaluation and Risk Management
Usability Engineering for Medical Devices
Monitoring of Products on the Market (approx. 2 days)
Defect and Complaint Management
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
Vigilance, reporting procedures, and complaint handling
EUDAMED in the post-market context
Communication with regulatory authorities and notified bodies: Feedback and reporting
Audits and Inspections (approx. 1.5 days)
Application of EN ISO 13485
Audit planning, audit execution, and follow-up
Certification bodies or the competent authorities
EN ISO 13485 vs. MDR (Medical Device Regulation)
ISO 13485 as the basis for the global MDSAP (Medical Device Single Audit Program)
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Statistics and data analysis
Statistical basics (approx. 6 days)
Measurement theory basics (population, sample, sample types, measurement, scale levels)
Univariate descriptive statistics (frequency distributions, central measures, measures of dispersion, standardization, histograms, bar charts, pie charts, line charts, box plots)
Bivariate descriptive statistics (measures of correlation, correlation coefficients, crosstabs, scatter plots, grouped bar charts)
Basics of inductive inferential statistics (probability distributions, normal distribution, sampling distribution of the mean, significance test, null hypothesis test, significance level, effect size, parameter estimation, confidence intervals, error bar charts, power analysis, sample size)
Data preparation and data cleansing with suitable software
Descriptive analysis
Visualization of statistical results
AI-supported analysis and interpretation of statistical results
Methods for comparing two groups (approx. 5 days)
z-test, t-test for one sample
t-test for independent and related samples
Pretest-posttest designs with two groups
Supporting significance tests (Anderson-Darling test, Ryan-Joiner test, Levene test, Bonett test, significance test for correlations)
Nonparametric methods (Wilcoxon test, sign test, Mann-Whitney test)
Contingency analyses (binomial test, Fisher's exact test, chi-square test, cross-tabulations, measures of association)
Interpretation of test results
AI-supported interpretation of results
Basics of regression analysis (approx. 2 days)
Linear regression
Model interpretation
AI-supported model interpretation
Correlation analysis
Methods for comparing the means of several groups (approx. 3 days)
One-factorial and two-factorial analysis of variance (ANOVA)
Post-hoc analyses
Interpretation of group differences
Multi-factorial analysis of variance (general linear model)
Fixed, random, crossed and nested factors
Multiple comparison methods (Tukey-HSD, Dunnett, Games-Howell)
Interaction analysis
Power analysis for variance analyses
Introduction to Design of Experiments (DoE) (approx. 1 day)
Full factorial and partial factorial experimental designs
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Changes are possible, the course content is updated regularly.
After completing the course, you will be familiar with the regulations, standards, and conformity assessment procedures for medical devices and will be able to contribute to the implementation of EN ISO 13485 and ISO 14971.
You will also understand the basics of statistics, be able to process and evaluate data and present, explain and interpret statistical data analyses and results using graphics.
The course is aimed at people with a degree in engineering, natural sciences, production managers, quality officers and all employees working in the areas of regulatory affairs, development, production, quality control and quality assurance in medical device companies.
In order for a medical device to be sold on the German and European market, medical device regulations must be complied with during production. Specialists who are familiar with the production process and the applicable quality standards are in high demand in the medical device industry. In addition, such knowledge also helps the pharmaceutical industry to better understand the regulatory requirements at the interface between the pharmaceutical and medical technology industries.
A sound knowledge of statistics is a valuable additional qualification that is in great demand in industrial research and development, in drug development, in the supervision of medical studies, in finance and insurance, in information technology or in public administration.Your meaningful certificate provides a detailed insight into the qualifications you have acquired and improves your career prospects.
Didactic concept
Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).
You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.
Virtual classroom alfaview®
Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.
The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).