Successfully pass audits and inspections instead of causing quality bureaucracy

 

Most companies find quality management audits and FDA inspections stressful. Our regulatory affairs experts and lead auditors will help you to quickly

• pass these audits (ISO 13485, ISO 9001) and inspections (21 CFR part 820),

• establish concise and customized quality management systems (QM systems),

• streamline your existing QM system, and

• achieve regulatory compliance fast, with minimum efforts and without having to read hundreds of regulatory documents.

Precise and streamlined processes will help not only to achieving regulatory compliance but also to developing high quality products in time and budget.

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How we help to pass ISO 13485 audits and FDA inspections fast, easily and successfully

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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 existing quality manuals

  • 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

 

Contact us. With our help you will

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• 100% safely pass your audit

• bring your products to the market in time and budget,

• accelerate and improve your development and production.

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What it costs and how long it takes to establish an ISO 13485-compliant quality management system

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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

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We are so fast for several reasons:

1. Experience
   We are experienced and have done it a couple hundred of 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 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​