Based on 12 years of experience, we provide tailor-made advice on business development in Europe. As a small firm, we are in a flexible position to provide customized and cost-effective solutions for our clients. We also manage a network of experts in medical device industry who offer cost competitive services on all aspects of developing your business in the European Union. In doing so, we wish to develop long-term business commitment with our clients and partners.
You might want to consider us as your one-stop shop for developing the market for your medical device products in major European Union markets.
We offer professional support and the benefits of long experience on:
- Setting-up, Upgrading and Managing Quality Management Systems
- CE-marking of Medical Devices (including In Vitro Diagnostics)
- Submitting for FDA and Health Canada approval for Medical Devices (including In Vitro Diagnostics)
- Taking care of Regulatory Affairs
- QMIC Implementation
We work in a flexible way:
- Single advice
- Short projects
- Long-term projects
- In-house
- Externally
Level 1: Basic
- Setting-up, Upgrading and Managing Quality Management Systems
- General information and advice on product registration; including procedures, desired documentation, cost indication, time-line, etc
- General information and advice and setting-up a quality management system
- Execute a feasibility study with regard to the possibilities of marketing authorisation of the present documentation
Level 2: Project basis
- Setting-up, Upgrading and Managing Quality Management Systems
- CE-marking of Medical Devices (including In Vitro Diagnostics)
- Submitting for FDA and Health Canada approval for Medical Devices (including In Vitro Diagnostics)
- Accompany / advice with respect to Regulatory Affairs (RA) and Quality Issues during product or process development
- Setting up quality management systems
- Updating and maintaining your Marketing Authorisation and Quality Management System
Level 3: Dedicated consultant
- We provide assistance to your Regulatory Affairs Manager or Quality Manager with regard to all relevant activities – See level 4
Level 4: BioTop Medical act as one of your employees
- Setting-up, Upgrading and Managing Quality Management Systems
- Regular presence at your office
- Planning and responsibility for Internal Quality-related Audits
- Your files and procedures will be generated, assembled and, if necessary, maintained by BioTop Medical
- Your employees will be trained by BioTop Medical and we will provide the required expertise in procedures related to Regulatory Affairs
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