Teake Bulstra

At BAAT Medical, we have partnered since 25 years with clients worldwide to bring over 300 orthopedic, active implantable, and pharmaceutical medical devices to market. Our multidisciplinary team offers comprehensive services from design and development to compliance with ISO 13485, MDR, and FDA standards. With a proven Quality System, we ensure every project meets the highest regulatory requirements. Let’s work together to bring your medical device to life . **Our services: **Support you in building a compelling business case to attract investor funding, backed by our 25 years of MedTech expertise and our global industry network. Accelerate time-to-market with our integrated development process and engineering expertise tailored for MedTech. From prototype to scale, we create a flexible, cost-effective supply chain with access to our network of trusted, high-quality suppliers Navigate FDA and CE requirements to secure certification through our regulatory expertise and ISO-standard compliance. Provide a lean QMS system with QA support to allow focus on your core business Prove your device’s value with clinical data that highlights patient benefits, resonates with investors, and aligns with market needs. Minimize legal risks with our comprehensive support in warehousing, distribution, post-market surveillance and change control.