WHAT WE DO
Evaluation of compliance with the regulatory requirements provided for each product category. Classifiation of the product in a matrix which includes the product characteristics, mechanisms of action, intended use and markets.
in-vitro and in-vivo studies, clinical investigation
n-vivo and in-vitro studies to assess the safety of a product acconrding to the relevant regulation. Clinical investigation, clinical experiences and post market clinical follow-up to evaluate the safety and the performance of a product.
Clinical evaluation, made by qualified medical personnel, devoted to validate the safety and performances of medical devices according to the newst guidelines and regulation.
Independent evaluation of the company organization with the aim of designing a management system that best fits the organization. How to choose the right partner for certification, taking into account the policies, objectives and positioning strategies.
Training courses designed specifically for your Company (in-house) and standard training courses in classroom. All courses provide verification of effectiveness, certificate of attendance, and a specific assessment for each participant.
Audit of 1st and 2nd parts performed by qualifid auditors. Qualifiation and maintenance audit of product and critical suppliers in Europe and Extra-EU. Compliance audit for medical devices (according to Dir. 93/42/EEC, Canadian regulation, FDA, and ISO 13485 requirements), food supplements and cosmetics products.
WHO WE ARE
Audit & Governance is a Swiss Company that presents itself as a strategic choice for technical training, system and product certifications, testing activities in-vitro, in-vivo and in human.
The idea to start this challenge with the market was born from the desire to share our experience and make it available.
The training and information sources available on the market rarely offer technical working tools. In many cases you get a well-made training but without objectively verifiable references to reality.
The difficulty of applying the information received leads to a complexity and rigidity of the documentation that does not fit the business context of the Company. The rigidity and document complexity is seen as a super-structure of costs that slows the development and often the documentation is handled separately and asynchronously with the development activities, almost as a secondary activity.
We have a proposal, we have validated a methodology and we have a mission: We want to be the tailor who gives value to the fabric.
Our methodology aims to identify the most appropriate regulatory framework outlining the path to follow with timing and methods. Our methodology aims at making independent companies and to enable them to use the tools and information received during our support.
Our mission is to guarantee 101% satisfaction chances.
Our business is not doing consulting but to give you back your time and stimulate your need innovate.
For this reason we are what and who you're looking for.
share experiences and make it available
references to reality
without complexity and rigidity of the documentation
Identify the most appropriate regulatory framework