Meeting consistent and exacting quality, safety and regulatory requirements are some of the principal challenges faced in the manufacturing and marketing of medical devices. Further demands are placed on manufacturers, dealers and suppliers in the MedTech sector by the implementation of new regulations that need to be adhered to.
BakerHicks offer you expertise, experience and professional project management at all times.
Capabilities in this sector
Project Management & Controlling
With our hands-on approach to project delivery strategies, our experienced project managers and their teams define and manage schedules, budgets and deliverables throughout the project lifecycle.
We understand our clients’ operational and quality process needs, applying industry leading ideas from some of the best minds in our field.
Intelligent environments and smart processes. Innovative integrated laboratory solutions delivered by our expert engineers, scientists and architects.
We specialise in full facility design, integrating complex functional processes and laboratories throughout their entire life cycle.
Responsible Person / Qualified Person & Regulatory Affairs
We offer efficient support through our FvPs/QPs, Quality and Regulatory Affairs managers in the areas of GMP and GDP.
GxP Compliance Services
Our experts have in-depth knowledge in all GxP areas and support you in complying with regulatory requirements.
We support our clients with efficient commissioning, qualification and validation activities and ensure a punctual system handover for a successful start-up.