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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. 1 day)
Basics of QM
Q-methods and Q-tools
QM - Medical devices ISO 13485 (approx. 1.5 days)
Structure, scope, area of application of ISO 13485
Relationship between MDR/IVDR and ISO 13485
ISO 13485 in the context of the requirements of 21 CFR Part 820
Artificial intelligence (AI) in the work process (approx. 0.5 days)
Document review with AI support
Regulatory requirements (AI Act)
Requirements for management systems (approx. 3 days)
Management standard ISO 9001:2015
Provision and management of resources
Basics in the area of measurements and tests
Requirements for measuring equipment management for medical devices and diagnostics
Process-oriented QM (approx. 2 days)
Importance of processes, process orientation, process description and process validation
Corrective and Preventive Actions (CAPA process)
Continuous improvement process (CIP)
Monitoring products on the market (approx. 2 days)
Error and complaint management
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
European database EUDAMED
Reporting procedures and complaint handling
Communication with authorities and notified bodies: Feedback and reporting
Documentation systems (approx. 3 days)
Basics of general QM documentation, document control and archiving
Validation parameters (IQ, OQ, PQ)
Summary Technical Documentation: STED
Risk management (approx. 2 days)
Importance of the risk management standard ISO 14971
Product and process risks
Risk areas and typical product risks
Audits and inspections (approx. 2 days)
Application of EN ISO 13485
Certifiers and the responsible authorities
EN ISO 13485 vs. MDR (Medical Device Regulation)
ISO 13485 as the basis for the global MDSAP (Medical Device Single Audit Program)
Auditor duties, audit planning and implementation
Audits taking into account the implementation of legal and technical requirements
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 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 13485:2021 and ISO 14971:2021.
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).