SERVICES
Regulatory and Quality Consulting Services
Hopestone provides practical, senior-level support across regulatory affairs, quality systems, audit readiness, risk management, and product lifecycle challenges for IVD and medical device companies.
Regulatory Affairs Strategy
Regulatory pathway assessment, submission planning, agency interaction preparation, change impact evaluation, and global regulatory strategy support.
Quality Management Systems
ISO 13485-based QMS support, process improvement, SOP development, management review, CAPA, complaints, and practical compliance operating models.
Audit & Inspection Readiness
Mock audits, FDA inspection readiness, notified body preparation, internal audit support, observation response, and remediation planning.
Risk Management & Design Controls
Support for ISO 14971 risk management, design controls, requirements traceability, verification and validation planning, and lifecycle documentation.
IVD & Medical Device Lifecycle Support
Product lifecycle support for IVDs, medical devices, software-enabled devices, design changes, technical documentation, and post-market quality activities.
Fractional QRA Leadership
Senior-level regulatory and quality leadership support for companies needing interim guidance, team mentoring, operating model development, or executive advisory support.