Medical Device GMP & Regulatory Consulting
Professional consulting services for
Medical Device GMP, Regulatory Affairs, and ISO Certification.
BESTTANT is your trusted partner in the medical device industry
BESTTANT, a combination of 'BEST' and 'CONSULTANT', is a specialized consulting firm that helps medical device manufacturing and importing companies solve GMP, regulatory, and certification challenges.
Our consultants, former medical device GMP auditors, build efficient and effective quality management systems from an auditor's perspective while meeting your company's needs.
Based on our deep understanding of the medical device industry, we provide systematic and practical solutions for KGMP compliance, regulatory approval, and ISO certification.
We possess extensive experience and professional knowledge in medical device GMP, regulatory affairs, and ISO certification.
We prioritize our promises to clients through transparent and honest consulting.
We provide practical, implementation-focused solutions rather than just theory, ensuring successful results.
Professional Medical Device GMP & Regulatory Consulting Services
We provide consulting services for building and operating quality management systems to comply with KGMP (Korean Good Manufacturing Practice) for medical device manufacturers and importers.
We provide comprehensive consulting for the entire process of obtaining medical device manufacturing and import permits and certifications, including technical documentation and application procedures.
We provide facility standard review, document preparation, and application agency services for medical device manufacturing and import business registration and licensing.
We provide system establishment and consulting services for obtaining ISO 9001 (Quality Management), ISO 14001 (Environmental Management), and ISO 13485 (Medical Device Quality Management) certifications.
We provide audit preparation, audit response strategies, and non-conformance improvement support services for ISO 9001/14001/13485 certification audits.
We provide internal audit services and improvement activity support for the effective operation of KGMP and ISO quality management systems.
We provide pre-inspection and preparation before MFDS KGMP regular surveys, as well as consulting for prevention and improvement of findings.
We provide professional training programs for KGMP/ISO internal auditor development to strengthen your organization's self-quality management capabilities.
Create growth opportunities with BESTTANT
Tel: 010-4546-0875
#1105-10, 11F, 1246 Gyeongui-ro, Paju-si, Gyeonggi-do
(Wadong-dong, Yueun Tower 8)
Weekdays: 09:00 - 18:00
Closed on weekends and holidays