Partners

Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems.

Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook’s team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity.

Nocturnal offers a unique combination of medical device expertise and an innovative business model with fixed-cost pricing to help early stage medical device companies accelerate and derisk the path to commercialization.

Specializing in class II and class III, implantable, and lifesaving devices, Nocturnal’s milestone-based pricing allows device startups to minimize risk and increase investor confidence by meeting critical product development milestones with a predictable cash outlay.

RegTrac is a global regulatory tracking platform designed to help compliance and finance professionals stay informed about regulatory changes. Their services include medical technology, consumer healthcare, authorized rep, and training and mentoring solutions.

RegTrac captures a wide range of regulatory developments, including final rules, proposed rules, concept releases, guidance, and enforcement actions. RegTrac aims to ensure that businesses are prepared for and can plan ahead of regulatory changes.

Saylan Consulting, LLC is a specialized engineering and regulatory consulting firm with experience in medical device design and development. They offer comprehensive services across the product lifecycle, including clinical user needs discovery, market assessment, and regulatory strategy. Their expertise spans various medical devices such as craniomaxillofacial implants, transcatheter heart-valve stent grafts, and laparoscopic instruments.

Saylan Consulting, LLC also provides support in new product development, quality management system setup, and training workshops focused on areas like risk analysis, human-centered design, and design verification.

Intent Venture Management, LLC is a consulting firm specializing in investment and commercialization strategies for the healthcare and life sciences sectors. The firm offers a comprehensive suite of services, including investor diligence, deal structuring, financial planning, grant writing, and fundraising.

They also provide expertise in regulatory compliance, reimbursement strategies, clinical trial planning, and quality management system preparations. Intent Venture Management, LLC assists clients such as venture capital investors, manufacturers, payors, startups, and research institutions.

Vital Compliance is boutique consultancy specializing in regulatory and quality compliance for small and medium-sized medical device companies. They strive to help clients navigate complex compliance requirements with simplicity and efficiency and are known for a strong emphasis on security and privacy. 

Vital Compliance offers services in areas such as quality management systems, regulatory approvals, and statistical programming, emphasizing a “minimum viable” approach to address compliance gaps and provide incremental improvements.

Boomerang Ventures is a venture capital firm and innovation studio dedicated to transforming healthcare through technology. They offer a dual approach: Boomerang Studio and Boomerang Fund. The Boomerang Studio collaborates with founders to develop and launch connected health technologies, while the Boomerang Fund invests in early-growth-stage companies poised to disrupt healthcare delivery.

By partnering with founders, investors, and institutions, Boomerang Ventures aims to accelerate the development and adoption of innovative healthcare solutions, ultimately improving patient outcomes and transforming the healthcare ecosystem.

Med-Sherpa, Inc. specializes in regulatory compliance and quality management systems (QMS) for small and medium-sized medical device manufacturers. They refer to themselves as “consultractors,” which are consultants and contractors in one. Med-Sherpa is known for being a different kind of regulatory and QMS service for medical device manufacturers. Their services include strategic planning, daily management, and progress tracking, all focusing on safety, compliance, efficiency, and transparency.

Med-Sherpa serves as a silent partner, delivering expert regulatory and QMS support when needed, and remains silent without adding stress when not.

Proxima Clinical Research (Proxima CRO) is a contract research organization (CRO). They specialize in providing regulatory, clinical, and quality research services to life sciences companies across all stages, from emerging innovators to established enterprises. Their vision includes the C.A.U.S.E. they work for: Customer, Accountable, Unity, Success, and Excellence. 

Proxima’s mission is to help clients overcome challenges and bring new drugs and devices to market efficiently and effectively.

Helix Medical is a regulatory and quality consulting company that guides its customers through the medical device regulatory landscape. Their expertise in quality and regulatory consulting includes regulatory strategy, U.S. FDA submissions, Risk management, and design controls, audits, and much more. They also offer quality management systems template bundles that align with every stage of your business.

Compliance Solutions is a global consultancy specializing in regulatory affairs and quality management for the medical device and in vitro diagnostics (IVD) industries. Their services encompass CE marking, FDA 510(k) submissions, clinical trial guidance, quality management system (QMS) implementation, and acting as EU and UK authorized representatives. Compliance Solutions helps clients navigate complex regulatory landscapes efficiently, ensuring compliance across multiple markets.