At Spruce Group, we deliver targeted consultancy services for medical device, pharmaceutical, and regulated manufacturing companies. Our team of experienced professionals brings clarity, efficiency, and compliance expertise to complex operational and regulatory challenges. With deep sector knowledge and a trusted network of specialists, we offer rapid deployment, direct support, and tailored solutions—without the need for third-party agencies.
Project completed
Years of experience
Launching a business in a regulated industry requires strategic planning, compliance alignment, and structured execution. Our start-up services help guide new businesses through the complexities of quality, regulatory, and operational requirements.
Services include:
• Start-Up Pack – A structured approach to regulatory, quality, and operational setup.
• Coaching – One-on-one guidance to navigate compliance and industry requirements.
• Timeline and Progress Analysis – Developing milestone-based roadmaps to keep projects on track.“
We give you the space to innovate.”
A strong Quality Management System (QMS) ensures regulatory compliance, product safety, and operational efficiency. We provide expert guidance to establish, maintain, and improve your quality processes.
Services include:
• Deviations in Quality & Complaint Handling – Root cause analysis, CAPA management, and audit readiness.
• QMS Documentation – SOPs, work instructions, policies, and compliance records.
• Regulatory Gap Analysis – Identifying gaps between current processes and regulatory expectations.
• Timelines and Costing – Strategic planning to optimize compliance without overspending.
Regulatory References:
ISO 13485 (Medical Device QMS)
FDA 21 CFR Part 820 (Quality System Regulation)
EU MDR 2017/745 & IVDR 2017/746
Efficient project management ensures timely product development, compliance adherence, and cost control.
Services include:
• Gap Analysis – Identifying risks and weaknesses in product lifecycle stages.
• Timelines – Establishing realistic deadlines for project execution.
• Costing & Budgeting – Ensuring financial viability of projects while maintaining compliance.
Applicable Standards:
ISO 31000 (Risk Management)
PMI PMBOK (Project Management Best Practices)
Ensuring process consistency, equipment reliability, and regulatory compliance through structured validation methodologies.
Services include:
• Process Validation – Ensuring manufacturing processes meet regulatory expectations.
• Equipment Validation – IQ, OQ, PQ for manufacturing and laboratory equipment.
• Software Validation – Compliance with FDA 21 CFR Part 11 and GAMP 5 guidelines.
• Test Method Validation (TMV) – Ensuring analytical methods provide accurate and repeatable results.
• Biocompatibility Validation – Ensuring materials meet ISO 10993 requirements.
Regulatory References:
FDA 21 CFR Part 11 (Electronic Records & Signatures)
ISO 13485 (Medical Device QMS)
ISO 17025 (Testing & Calibration)
Strategic sourcing and supplier qualification ensure product quality and cost efficiency.
Services include:
• Supplier Sourcing & Pricing Optimization – Finding and evaluating reliable vendors.
• Supplier Audits – Ensuring compliance with ISO and GMP standards.
• Contract Manufacturing Oversight – Managing third-party production partners.
Regulatory References:
ISO 9001 (Quality Management)
EU MDR/IVDR (Supplier Qualification Requirements)
Validating sterilization processes is critical for medical devices and pharmaceuticals.
Services include:
• Sterilization Method Validation – Selecting and validating Ethylene Oxide (EtO), Gamma, or Steam sterilization methods.
• Bioburden & Endotoxin Testing – Ensuring microbiological safety.
• Regulatory Submissions – Preparing documentation for regulatory approval.
Applicable Standards:
ISO 11135 (EtO Sterilization)
ISO 17665 (Moist Heat Sterilization)
ISO 11737 (Bioburden Testing)
Seamless transfer of products and processes from R&D to full-scale production.
Services include:
• R&D to Production Transfers – Ensuring smooth transition without loss of quality.
• Process Scale-Up & Line Transfers – Adapting processes for large-scale manufacturing.
• Regulatory Compliance Alignment – Ensuring transfer processes meet FDA, EMA, and ISO standards.
Applicable Standards:
Good Manufacturing Practices (GMP)
ISO 13485 (Medical Devices)
Ensuring facility and equipment readiness for regulated manufacturing.
Services include:
• Facilities Qualification – Cleanroom validation, HVAC, and utilities.
• Equipment & Instrument Qualification – IQ, OQ, PQ for lab and manufacturing equipment.
• Manufacturing Process Validation – Ensuring production consistency.
Regulatory References:
ISO 14644 (Cleanroom Standards)
FDA 21 CFR Part 211 (Pharmaceutical Manufacturing)
Precise measurement and calibration services to maintain accuracy and compliance.
Services include:
• Calibration Program Development – Setting up compliant calibration schedules.
• Instrument Qualification – Ensuring accuracy in laboratory and manufacturing environments.
• Metrology Compliance – Ensuring traceability and precision.
Applicable Standards:
ISO 17025 (Calibration & Testing)
NIST (National Institute of Standards & Technology)
Protecting critical infrastructure and ensuring compliance with the latest cybersecurity regulations.
Services include:
• Risk Management & Cyber Resilience – Identifying vulnerabilities and mitigating risks.
• Data Integrity & Security – Ensuring compliance with GDPR, FDA Part 11, and ISO 27001.
• Incident Response Planning – Developing strategies to prevent and respond to cybersecurity threats.
Regulatory References:
EU NIS2 Directive (Cybersecurity for Critical Sectors)
ISO 27001 (Information Security)
Thank you for considering Spruce Group as your trusted partner. We are driven by the pursuit of your success and are eager to work collaboratively with you to unlock new opportunities and create a brighter future for your business.
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