Your fast-track to ISO 13485 certification
How we help to pass ISO 13485 audits and FDA inspections fast, easily and successfully
Our auditors and QM experts have assisted literally hundreds of medical device companies to pass audits and inspections successfully (100% success rate) by:
Creating Quality Manuals
- writing your quality policy and your quality goals,
- identifying your processes and document it in procedural requirements (e.g. development, production, supplier control, CAPA, market monitoring, documents control, internal audit, management review, etc)
- describing the interaction and interdependencies of processes,
Evaluating and Improving
- e.g. adding missing content to achieve the standards compliancy,
- eliminating unnecessary requirements thereby purging quality manuals
- redesigning processes in order to achieving the quality management goals: bigger success in the market with your high quality products and services
- performing mock-up audits to prepare the quality management system and to prepare the whole company for audits and inspections
With our help you will
- 100% safely pass your audit
- bring your products to the market in time and budget,
- accelerate and improve your development and production.
What it costs and how long it takes to establish an ISO 13485-compliant quality management system
The costs for establishing an ISO 13485-compliant quality management system depend on factors such as:
- Size of organization, number of locations and branches, number of employees
- Scope of quality management system (e.g. development, production, sales, support, etc.)
- Preexistence of other quality management systems e.g. ISO 9001
- Management commitment and involvement of employees
However, because we have already assisted over 100 companies and we have a clear focus on small and medium size companies, we can assess the efforts precisely. Typically, it takes us between 7 and 14 days to compile the quality manual, including all procedures, templates and forms.
Why we are as fast
We are so fast for several reasons:
We are experienced and have done it a couple hundred of times
- Avoiding superfluous documents
We are auditors ourselves. We even train auditors and know exactly what is necessary. Therefore we only compile documents that are legally required or/and helpful to develop products better and faster. We hate extensive bureaucracy and unnecessary paperwork.
Our focuses are small and medium size manufacturers and engineering service providers that develop active medical devices that contain or that are software.
- Joined effort
We work closely with our clients. The more work they would like to take on, the lower our efforts and costs. Our dedication is to empower our clients as fast as possible and to share the workload rather than maximizing our revenue.
- Proven templates
There is no need to reinvent the wheel over and over again. There are lots of documents which always look alike. Therefore, we work with templates which reduces workload, complexity and costs. Obviously, SOPs, for core processes as development, have to be specific for each company.
The roadmap to ISO 13485 certification
A typical project looks like this
- Day 1 and 2: Initial workshop
We get to know you and your company, review existing documents, let you explain your process and commonly discuss potential for improvements.
- Day 3 to 7: Writing the documents
We compile your specific quality management system documentation. You will be surprised by the outcome.
- Day 8 and 9: Fine tuning
We discuss open issues and fine-tune the documents and the system.
- Day 10: Hand-over and training
We introduce your team to the new or updated quality management system and provide a training on how to use the system (this goes very fast). Then you start working with your system.
- Day 11-12 (optional): Mock-up audit
A mock-up audit helps you to identify non-conformities. You are perfectly prepared for the real audit inspection.
Contact us now! We are happy to answer your questions and discuss with you the best way to establish your quality management system.
What our customers say
“Without your competent and highly efficient consulting, the certification would not be possible. Also the team work with Mr. Thern, Mr. Geis, Mr. Gerhart, was really goal oriented and pleasant- and i have learned so much!”
Dr. Niels Bojunga, Molecular Health
"Hi Mr. Prof. Dr. Johner,
I have attached the PDF-File of our certificate as an evidence of a successful certification according to ISO 13485.
Once again thank you very much for your active support. Without it we would probably not able to make it further. [...]
Your [QM Officer], Small Medical Product Manufacturers
"With practical help from Professor Johner and his team, we managed to develop a ‘liveable’ QM System for our company and successfully certified it according to ISO 13485. We really appreciate the pleasant collaboration and the fact that we managed to get our project done in time and at estimated cost."
Dominik Blei, Head of Development Company for Patients Help
"Beginning of September we had our 1st maintenance audit and had also passed this one! I would like to thank you and and also Mr. Waitron for the support!”
Lisa Hopp, Head of QM, SUPSmed
“We had two really great audit days […] and Mr. [Auditor from the notified bodies] had complimented our company. Thank you very very much once again for an excellent work and assistance. Without your help we would possibly fail. We made a good impression with the development plan :-).”
Björn Maucher, HIM, Health Information Management GmbH
“Our audit is done and we “passed”. There was no non-compliancy and tips regarding potential improvements. The (Auditor) team had particularly complimented the technical basic of the QMS.
In this case, big thanks to you from me and the whole team for a great assistance!"
Klaus Mueller, xmachina GmbH, Heidelberg