Ken Block Consulting

Ken Block Consulting is a private, revenue-generating services firm providing expert regulatory and quality compliance consulting to medical device companies targeting the US market. With a core focus on FDA regulations, the company offers end-to-end support from pre-market strategy and 510(k) submissions to post-market surveillance and inspection readiness. Leveraging offices in the US and Japan, KBC serves a global clientele, positioning itself as a critical partner for navigating complex regulatory pathways to commercial success.

Regulatory affairs and quality compliance expertise for medical devices, encompassing FDA QSR, ISO 13485, risk management, validation, and submission strategy. The firm's intellectual capital and procedural methodologies serve as its core platform.

KBC competes in the regulatory consulting niche against a range of players, from large global Contract Research Organizations (CROs) and professional services firms to smaller boutique consultancies and independent consultants. Its differentiation lies in its focused expertise on medical device FDA compliance, international office presence for global clients, and stated reputation for hands-on, results-oriented service.