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 achieve 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

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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 the 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-sized 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:

  1. Experience
    We are experienced and have done it a couple of hundred times 
  2. 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. 
  3. Specialization
    Our focuses are small and medium-size manufacturers and engineering service providers that develop active medical devices that contain or that are software.  
  4. 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. 
  5. Proven templates
    There is no need to reinvent the wheel over and over again. There are lots of documents that always look alike. Therefore, we work with templates that reduce 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 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.