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EXPERTISE On this page you fill find the following informative points, please scroll down EN ISO 13485:2016, MDR 2017/745
1st and 2nd Party Auditor Medical Devices
Regulatory Affairs Medical Devices International
Expert Quality Management Medical Devices International
Training Course Auditors and Experts , QS, the Notified Body Switzerland: Medical Device Training
Schulung Notified Body Switzerland: Guideline 93/42/EWG, EN ISO 13485:2012, NBOG BPG 2010-1
„Regulatorische Anforderungen an Medizinprodukte“ DIN Akademie Beuth Verlag
Applied Standards
Medizin-Materialien
Fachgebiete
Medizin-Technik
Biokompatibilität, ISO 10993

point 2:
1st and 2nd Party Auditor Medical Devices (Certificate: TUEV Akademie)
- Outsourcing of processes in the medical device industry
- Validation of processes in the medical device industry
- Auditor in the medical device industry

point 3:
Regulatory Affairs Medical Devices International (Certificate: University Ulm Professur der Fakultät Mechatronik und Medizintechnik & TUEV Akademie )
Certificat and certified specialist: Regulatory Affairs Medizinprodukte International

point 4:
Expert Quality Management Medical Devices International (Certificate: TUEV Akademie)
- QM-representative (QMB) for medical device manufacturers
- CAPA & Co for medical device manufacturers
- Approval of medical devices for the USA
– QSR.• Quality management system according to EN ISO 13485:2016
- Risk Management according to ISO / EN ISO 14971

point 5:
Training Course Auditors and Experts , QS, the Notified Body Switzerland: Medical Device Training , Training Topics:
• The new documentation of the notified body switzerland and the application for audits according to ISO 13485 and conformity assessments according directive 93/42/EEC
• The European CE marking approach and ist legal and operational basis
• Conformity assessment routes and quality assurance requirements for the various risk classes
• Importance and roll of clinical data
• Regulatory significance of risk managment and process validation
• Steps required für post market surveillance for different risk classes
• Criteria for reporting adverse incidents under the vigilance system
• Manufacturers regulatory responsibilitites, including reporting of changes to products and the QMS System to the Notified Body.
• Technical Documentation requirements
• Relevance of recent changes to the Medical Device Directives
• Surveillance audits, unannounced audits and supplier audits in compliance with the directives.

point 6:
Schulung von QS, Notified Body Switzerland: „ Guideline 93/42/EWG, EN ISO 13485:2012, NBOG BPG 2010-1 QS-Notified Body Switzerland: 2015
Auditing according to EN ISO 13485:2012 in connection with the evaluation of technical documentation for medical devices. New processes and forms, reporting, formulation and deviations, audit behaviour. Requirements for product-related auditing such as supplier audits of medical device manufacturers. Introduction to the new requirements of ISO 13485:2015 (Experts at that time were counting on the publication 2015, then it became ISO 13485:2016, year 2016, so before this new standard came out definitively, we had already dealt with it intensively. Training from the Notifed Body itself. Highly interesting knowledge of specialists.

point 7:
„Regulatory requirements for medical devices“ DIN Akademie im Beuth Verlag 2013:
Overview of the regulatory requirements for medical devices
- European directive (90/385/EWG, 93/42/EWG, 98/79/EG)
- Medical Devices Act and Ordinances
- Classification and conformity assessment procedures
Impact of the amendments to the European Directives due to the 2007/47/EG
- Classification of medical devices
- Essential Requirements
- Technical Documentation
- EU-representative
- Machinery Directive 2006/42/EG
- Clinical Data Current amendments to the Medical Devices Act (MPG)
- Adoption of European requirements
- Tasks of the BfArM
- Approach concerning the clinical evaluation
- Occurrences in Clinical Trials
Application of harmonised standards
- Presumption character of harmonized norms
- Presentation of individual standards and current changes:
DIN EN ISO 13485,
DIN EN ISO 14971,
DIN EN ISO 62304,
DIN EN ISO 62366
Assistance for the implementation of regulatory requirement
- European guidelines (MEDDEV)
- NBOG- und EK-Med Papers
- Tips and hints from practice

point 8:
STANDARDS
Applied Standards
ISO 13485: 2016 Quality management systems - Requirements for regulatory purposes
o ISO 14971: Application of risk management to medical devices
o IEC 62366: Application of usability engineering to medical devices
o EN 1041: Information supplied by the manufacturer of medical devices
o EN 60601: Medical electrical equipment and systems
o ISO 15223: Symbols to be used with medical device labels, labelling and information to be supplied
DIN EN ISO 15223-1:2017-04,
DIN EN 15986:2011-05
o ISO 14155 Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis o ISO 10993: Biological evaluation of medical devices
o European Directive 93/42/EEC
o MDR 2017 / 745
o German Medical Device Act (Paragraph 19(1), Swiss Laws, EU Laws & Regulations
o FDA Regulations for medical devices and for food,
o GOP, GxP, SOP, QMB...

point 9:
MEDICINE & MATERIALS
Material science - dentistry: Dr. med. dent.
Here you will find specialists who are not only trained in regard of medical topics, but also concerning materials and "precision mechanics" in the laboratory, - and that is precisely important when looking at medical devices. Materials include polymers, metals, ceramics and metals (gold, platinum, various alloys), techniques: welding, soldering, processing of polymers. This work is part of the training in special equipped laboratories on the university campus for many years, which dentists have to go through from day one. The number of hours of attendance at the university, often 50 hours a week, is thereby understandable. The dentists are thereby occupied working in the laboratory, in addition to studying medical subjects, and produce for years under tight supervision handmade custom-made products for their own patients. These work requires precision: micrometer range. The products are expected to function flawless for years, 24/7. Naturally work with microscope and magnifying glass is standard, in order to be able to produce precisely fitting custom-made products from precious metals, ceramics and a wide variety of polymers (hot and cold polimerizing). Therefore, dentists are very comprehensively trained, even in areas that are rather rare for physicians, such as materials science and precision mechanics . The unique years spent performing practical work with materials in the laboratory make these physicians specialists for details and precision work. Here is an excerpt of the subjects in which a dentist is trained and examined at the university up to the state examination:

point 10:
Specialities Dr med dent
Materials science,
physics,
chemistry,
biochemistry,
pharmacology,
dermatology,
otorhinolaryngology,
hygiene/microbiology,
pathology,
orthodontics,
ZMK diseases, (oral maxillofacial)
general surgery,
dental surgery,
tooth preservation,
dentistry,
radiology,
internal medicine
and much more.

pont 11:
MEDICINE & & TECHNIC
Doctoral Thesis Topic: development of medical devices University Kiel:
Department: Material Science
&
Department Oral and Maxillofacial Surgery
Doctoral Thesis "Mechanical investigations of screw prototypes (Zugschrauben) with the aid of a newly developed test apparatus "
Newly developed titanium ball and socket head screws from a german medical device company have been tested: whether they will have the desired advantages for the oral, maxillofacial and facial surgery when inserted into the bone. Self-tapping when screwing in and (!) while unscrewing. Gentle to the bone, but durable and providing healing in the correct position of the bones. Interesting work in the University of Kiel, which meant collaboration with material scientists, engineers, physicians, technicians and surgeons and medical device producing companies. The detected lIterature was so excellent that it was described as worthy for a habilitation. Despite moving abroad, the University of Kiel requested the entire literature folder of my doctoral thesis in order to start two more doctoral thesis, the Kiel doctoral student informed me. Quality. To this day we pay attention to details and are excellent concerning literature research and knowledge of studies. We take pride in this. Especially in the case of medical devices, an approval based on equivalence, supported with excellent studies from literature research, can sometimes even save the preparation of an own study, and thus immense costs. In the future, however, with the new regulations, more and more studies for medical devices will have to be prepared by the companies themselves. Our expertise is your benefit. Timely planning ensures medical device manufacturers complete access to the market.

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BIOCOMPATIBILITY We understand this topic particulary well. Material compatibility, solubility, effects on the immune system, allergies, anaphylactic reactions, special laboratories, alternative materials. Here we can look back on 30 years of experience and offer unique knowledge. Physicians, who are looking at the topic "for / as patients themselves", offer invaluable knowledge in this field. 25 years ago, we were already scientifically dealing with the biocompatibility issues of titanium materials that were then considered to be quasi inert. Today, with the increased demands on medical devices and the focus on clinical data, this is the central knowledge for the approval of medical devices and their lasting success on the market. Benefit from our knowledge.

point 13:
WE understand YOU and are happy to assist your business endeavours. We combine the medical knowledge of the doctor, the material scientist, the manufacturer, the specialist regulatory affairs and QM, qualification as 1st and 2nd part auditor and the training courses of the Notified Body itself let us understand the side of the Notified Body as well. Your advantage. We're happy to assist your company. Your 1st conversation - free!: contact us now!

EXPERTISE FOR YOU medicine, regulatory affairs, QM-systems, materials and technical aspects

INSTITUT DR SORGER

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