Audit MedTech
How the management will finally listen to you as a MedTech quality manager.
How the management will finally listen to you as a MedTech quality manager.
… so you can finally do your job in QM / Regulatory Affairs properly again.
Get a clear picture of your company’s current QM challenges, confirmed by external experts
Take advantage of our status as a renowned consulting firm to gain understanding from your management
Get the necessary budget released to tackle your regulatory challenges
This works completely without risk, because only a one- or two-day workshop is necessary
YOU DO YOUR BEST!!
in the company
As a quality assurance employee, you know the situation: there are internal problems you see and want to solve. But no one in management seems to listen to you or take these issues seriously.
The Good News? We know what you need.
You need an external supporter who clearly communicates to management through an audit what the current situation is, as well as what – and that a problem needs to be solved.
Our consultants are your qualified interlocutor who understands what your pains are, and at the same time is also sparring partner with whom you can tackle them together.
To the question: “Have you ever had customers who had problem X and solved it?” – we can always answer you with experience and best practices from past QM projects, so one thing is certain:
Your quality management gets back on track!
Benefits of an internal audit:
Finally consistent quality assurance
Independence through external view
End-to-end risk management
Ask a consultant, not a search engine
What is your current challenge in quality assurance?
Ask us a question – we will answer you immediately!
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Convinced?
Decide to make a difference now.
With our many years of experience, we support you in this!
StingOrg GmbH
Ask a consultant, not a search engine
What is your current challenge in quality assurance?
Ask us a question – we will answer you immediately!
StingOrg is an implementation-oriented consulting company that specializes in process optimization, quality management and lean management. Our goal is to create MedTech organizations that optimize themselves and produce responsible personalities. We don’t just see methodical problem solving.
For us, the focus is on people. During the consultation, we are part of your team and pull together with you.
We not only offer you the necessary expertise, and also an all-round carefree package. With StingOrg’s customer-oriented advice, you can be sure that your needs and wishes will be taken into account.
With our combined more than 70 years of industry experience, we offer you the right foundation to find the best and most sustainable solutions for you and your company.
Components of an internal audit
We discuss the list with all open points and propose a catalogue of measures individually adapted by us that will bring you and your organization step by step to your goal
We analyze your entire quality management system
We check whether everything is documented as required by the standard
We go through all areas to find potential problem areas.
We check whether the validation of your machine processes is sufficiently documented
Why an audit makes sense for you
The audit checks whether your processes and products comply with the applicable standards and regulations and also helps to improve the quality of your products and processes.
The internal audit is carried out by an independent StingOrg consultant who is not part of your company. This ensures that the audit is conducted objectively and impartially.
With the help of the audit, we identify possible risks and minimize them.
We can carry out an audit on the basis of these regulations and standards for you
ISO 13485
Die ISO 13485 ist eine Norm, welche Anforderungen an ein Qualitätsmanagementsystem für Medizinprodukt-Hersteller definiert. Im Kern soll das Ziel verfolgt werden, sichere und funktionstaugliche Produkte zu entwickeln.
EU MDR (2017/745)
Die europäische MDR (Medical Device Regulation)müssen Hersteller beachten, die Medizinprodukte in der EU in den Verkehr bringen wollen. Alle Medizinprodukte müssen eine eindeutige Identifizierung erhalten, die UDI (Unique Device Identification). Damit müssen die Produkte in der EUDAMED (European Database on Medical Devices) registriert werden. Die MDR legt Anforderungen an die Gebrauchsanweisung, weitere Begleitmaterialien und das sonstige Labeling wie Aufdrucke und Verpackungen genau fest.
EU IVDR (2017/746)
Die IVDR (In-vitro Diagnostika Regulation) fordert von den Herstellern klinische Studien zur Leistung und den Nachweis, dass Sicherheit und Performance der Produkte für die jeweilige Risikoklasse des Produkts angemessen sind.
MDSAP
Das MDSAP (Medical Device Single Audit Program) ist eine definierte Vorgehensweise, welche die 5 initial teilnehmenden Staaten (USA, Kanada, Brasilien, Japan und Australien) ausgearbeitet und vereinbart haben, um harmonisierte Vorgehensweisen bei Inspektionen durch ihre Behörden und Audits durch zugelassene Zertifizierungsstellen sicherzustellen. Eine „MDSAP Zertifizierung“ vereinfacht den Eintritt mit Produkten in die genannten Märkte und wird in der Regel durch die jeweiligen Länder, ohne eine zusätzliche Inspektion durch ihre verantwortliche Behörde, als ausreichend akzeptiert. Weitere Länder haben sich mittlerweile diesem Auditsystem angeschlossen bzw. akzeptieren Diese. Innerhalb der EU wird eine ausschließliche MDSAP Auditierung nicht als hinreichend akzeptiert.
MDSAP baut auf die ISO 13485:2016 auf und wird durch länderspezifische Anforderungen ergänzt. Weitere Informationen und Guidance-Dokumente zu MDSAP sind kostenlos erhältlich über die Homepage der U.S. Food and Drug Administration (FDA).
QSR (21CFR…)
Die QSR820 ist eine FDA-Verordnung, die die Anforderungen an das Qualitätsmanagementsystem von Medizinprodukteherstellern definiert. Die Verordnung legt fest, dass Medizinproduktehersteller ein Qualitätsmanagementsystem etablieren, implementieren und aufrechterhalten müssen, um sicherzustellen, dass ihre Produkte sicher und wirksam sind.
ISO 14971
Die Norm ISO 14971 bezieht sich hauptsächlich auf das Risikomanagement für Patienten, Anwender sowie weitere beteiligte Personen, Ausstattungen und die Umwelt. Sie legt fest, wie Medizinproduktehersteller verfahren müssen, um mögliche Gefährdungen festzustellen, die mit den Gefährdungen verbunden Risiken eingeschätzt und bewertet werden, und sie prüft wie wirksam Maßnahmen sind, die zur Risikobeherrschung herangezogen werden.
Customer satisfaction
satisfied customers
completed projects
Dare to do it!
We help you to whip your quality management back into shape.
That’s why we!
- You not only receive a review of your status quo, but also an action plan to achieve certification
- We support you in every way to find sustainable solutions for and with you
- You benefit from many years of experience in a wide variety of organizations and best practices for almost every QM problem
72.2% of our customers were able to increase their production output by 80%.
41.4% of our customers were able to improve their scrap reduction by 40% in production.
81.9% of our customers were able to reduce overdue CAPAS by 80%.
Your questions, our answers:
How much does the audit by StingOrg cost?
A consulting day costs 1,400€ at StingOrg. You can have it calculated here on the website how many consultant days will be necessary in your company
How much time do I have to do this?
The pure time required for the preliminary meeting (max. 1 hour) and that of the consultant day on site. After that, you will have your audit report available.
How is compliance with regulations and standards ensured?
Through the expertise and experience that our consultants bring to the table in the field of MedTech.
How are deviations and corrective actions handled?
The handling of the measures is primarily your responsibility. As part of the audit, these are shown without gaps.
What documentation and records are required for the audit?
All documents that you have in your company for the area we are auditing. Then we will check these documents.
Your contact person
Malte Stöckert
Managing Director and Founder of StingOrg
My mission is not to accept the fail of projects as the most likely option. With my entire team, I am committed to no longer accepting this in order to make successful projects the standard for our customers.
Book an initial consultation with me now! I look forward hearing from you.
Do you want to move
your business forward?
Let’s take the first steps together!