What we do
When your organisation strives to achieve Compliance to regulations within Medical Devices and In-Vitro medical Devices or implement, improve, or optimize your current approach to Quality within the same areas we are there to guide you through the process or drive your project.
We are your partner in Compliance and Quality.
We help your organisation scope Initiatives or Projects that need to be implemented. We contribute with Knowledge and Experience about establishing, driving and completing projects. In the process we provide Training to the organisations employees in their roles as subject matter experts, project participants or project managers as required. We assume responsibility as project managers for complete projects if need be, and we create results for and with your organisation and ensure that development can continue internally.
Compliance is the state of being and working in accordance with regulations, standards, guidelines or specifications, or the process of becoming so.
Compliance is a prevalent business concern, partly because of new as well as an ever-increasing number of regulations, standards and guidelines.
It is required that our clients are vigilant and maintain a full understanding of their requirements for compliance.
We support them on their journey.
Some clients need to implement a Quality Management System (QMS). Other needs to improve or optimize an existing QMS.
A well functioning QMS is often a requirement to achieve Compliance when operating in the field of Medical Devices and In-Vitro medical Devices.
We are experienced in ISO 13485 and trained lead auditors within this standard.
Some client need a project manager with knowledge and experience in the fields of Compliance and Quality.
We have +20 years of experience as project managers within:
Optimization of processes
Implementation and optimisation of business-critical IT systems (ERP/CRM)
Implementation of management systems
Compliance with regulations and standards
Ultimately all initiatives and projects are different. That is why we take on each and every project with open eyes and ears, and make sure that all issues are, or will be, taken care of. No one comes to agerholm.eu and lands between two chairs. In return, we have a chair for everyone who comes by for a cup of coffee and wants to talk about their challenges and talk about how we can do something about these together.
Make an appointment today, via email or phone. It’s not binding.
How we do
As mentioned, all initiatives and project are different. We adapt our approach to the needs of your organisation.
Strategy is the direction a client choose with the aim of achieving future success. The strategy sets out how the client intends to employ their resources. We help our client to set a direction that will bring them towards Compliance and fulfill Quality requirements.
Project or Interim Leadership
We are happy to take responsibility
From the project idea, through the scoping and design phase, implementation of the project and delivery of the desired solution and expected results.
At agerholm.eu, we specialize in developing and implementing projects for and with our clients. We always take the clients business and the clients current situation as a starting point.
If you have questions about a specific project or just want to hear whether an idea can be realized, you are welcome to contact André Agerholm.
KIT Invest ApS