At first
Quality management in the medical technology industry requires careful planning, effective implementation and continuous improvement. Managers in the field of quality management are constantly faced with competing demands.
As interim managers, we are experts in this field and can enter your organisation quickly and purposefully to achieve your specific quality objectives. Whether it is compliance with strict regulatory requirements, the implementation of quality standards or the optimisation of processes – we are your reliable partner.
Range of Services
- Ad-interim department management and mentoring/coaching for all Quality Assurance (QA/QA), Regulatory Affairs (RA), and Quality Management (QM) functions
- Support in setting up and certifying quality management (QM) systems for medical device or component manufacturers
- Preparation and follow-up of audits (FDA, notified bodies (NB))
- Training and seminars on all questions relating to QM, QA, CFR 820, ISO 13458, etc.
Exemples
- Your head of department position for Quality and Regulatory is vacant and you need a temporary replacement to continue managing your department.
- You have a potential manager, but they need job mentoring.
- You are setting up a company in the medical field and need support in preparing your company for the necessary certifications.
- Your company is facing an audit (notified body or authority (FDA))situation, you need to review your systems and prepare and train your employees and the system for the audit
Please feel free to contact us.
