(Download: Regulatory Consulting Services in PDF by Medistri)
As medical devices and pharmaceutical products progress from development to market entry, regulatory compliance becomes a critical success factor. Beyond testing and sterilization execution, manufacturers are increasingly expected to demonstrate a deep understanding of regulatory frameworks, validation principles, and lifecycle control strategies.
At Medistri, our MedBraid’s Regulatory Consulting Services are designed to support manufacturers in navigating these expectations with clarity, structure, and confidence.
Regulatory Expectations Are Increasing
Regulatory authorities worldwide, including the European Commission, notified bodies, and international health authorities, continue to raise expectations regarding documented evidence, process understanding, and internal expertise.
Manufacturers are no longer assessed solely on outsourced test results or third-party certificates. They are expected to:
- Demonstrate control over critical processes
- Justify validation strategies and worst-case rationales
- Maintain traceable documentation aligned with applicable standards
- Ensure internal regulatory knowledge is embedded within their organization
This shift makes regulatory consulting an essential component of a robust go-to-market strategy.
Medistri’s MedBraid Approach
At Medistri, our MedBraid Regulatory Consulting is delivered by consultants with deep industrial experience in sterilization, validation, and laboratory testing. Unlike purely advisory services, our approach is integrated and practical: we draw directly from our in-house sterilization operations (EO and steam), microbiological and analytical laboratories, and real-world regulatory interactions to provide actionable guidance tailored to your product and processes.
Our support is not limited to theory. It is grounded in real processes, real audits, and real regulatory interactions.
Core Areas of Support
We offer targeted consulting across the key domains that drive regulatory success:
1. Regulatory Frameworks and Standards Interpretation In-depth guidance on applying international standards critical to sterilization and product safety, including:
- ISO 11135 (EO sterilization)
- ISO 17665 (moist heat/steam sterilization)
- ISO 11737 series (bioburden enumeration and sterility assurance)
- ISO 11138 (biological indicators)
- ISO 10993-7 (EO residuals)
- Relevant sections of the European and U.S. Pharmacopeias
We help translate these requirements into clear, product-specific compliance strategies.
2. Sterilization Strategy and Validation Expert support in designing and justifying effective sterilization approaches:
- Method selection (EO, steam, or alternatives) based on product characteristics and materials
- Definition of validation protocols, worst-case configurations, and loading patterns
- Process qualification (IQ/OQ/PQ), revalidation planning, and ongoing routine monitoring
- Development of robust sterility assurance rationales and release criteria
3. Process Control, Documentation, and Submission Readiness Assistance in creating and reviewing high-quality documentation:
- Validation master plans, protocols, and final reports
- Regulatory justifications and technical dossiers for submissions
- Standard operating procedures (SOPs) integrated with your quality management system (ISO 13485, 21 CFR Part 820, etc.)
- Traceable records designed to withstand notified body audits and authority inspections
4. Knowledge Transfer and Capability Building To foster long-term independence, we deliver customized training and knowledge transfer:
- Practical workshops on sterilization science, validation principles, and regulatory expectations
- On-site facility visits or virtual sessions
- Mentoring to strengthen your team’s ability to manage future changes and audits
Integrated Support Across the Product Lifecycle
Medistri’s MedBraid Consulting is seamlessly embedded within our broader portfolio of sterilization, laboratory testing, cleaning/reprocessing, packaging, and validation services. This vertically integrated model delivers clear advantages:
- Coherent alignment between regulatory strategy and operational execution
- Faster iteration during development and reduced risk of late-stage non-conformities
- Consistent data integrity and compliance from pre-clinical proof-of-concept through commercialization
- A single partner for technical and regulatory needs, reducing vendor fragmentation
Regulatory compliance is dynamic, product modifications, scale-up, new standards, or updated guidance require ongoing adaptation. By partnering with Medistri early and continuously, manufacturers position themselves for audit readiness, efficient change management, and confident, sustained market presence.
If you are navigating complex sterilization validation, preparing for regulatory submissions, or seeking to strengthen internal capabilities, our team is ready to support your success.
To learn more about Medistri’s MedBraid Regulatory Consulting Services, please contact your dedicated Customer Success Specialist or or contact us at customerservice@medistri.com.
– The Medistri Team
#Medistri
Medistri is Europe's leading independent contract sterilisation company, founded in 2006 and headquartered in the heart of Switzerland. We are a global player providing essential infrastructure that powers healthcare innovation worldwide.
We serve customers of all sizes, from startups, university projects, and research institutes to Fortune 500 corporations, across Medical Devices, Pharmaceutical Packaging, and Biotech.
Medistri supports products at every stage of the lifecycle: pre-clinical development, go-to-market, and full industrialisation.
Our fully integrated, end-to-end in-house solution allows our customers to focus on what matters most: engineering, innovation, and development, while we manage the critical backend processes.
Our synchronised departments work together to provide a complete stack of services:
- Contract Sterilisation & Validation Services
- Contract Laboratory Services
- Contract Manufacturing Services
- Logistics Services
- Consulting Services
We help you accelerate time-to-market, reduce barriers to scale, and deliver safer, more sustainable healthcare solutions to patients around the world.
Medistri’s Solutions for Products in Pre-Clinical Phase
During the pre-clinical phase, execution is essential to validate concepts, generate reliable data, and establish a strong foundation for regulatory approval.
Medistri serves as your integrated infrastructure partner, delivering a comprehensive portfolio of in-house Solutions optimised for R&D and proof-of-concept development.
Our solutions encompass R&D treatment cycles (custom sterilisation protocols), cleaning & reprocessing, product assembly, and packaging, alongside specialised testing including biocompatibility, extractables & leachables, sterile barrier integrity, environmental conditioning, laboratory analysis development, batch release, and regulatory consulting.
This vertically integrated model minimises vendor coordination, expedites development iterations, guarantees data integrity and compliance from inception, and enables your team to prioritise core scientific and engineering advancements.
Positioning you for seamless progression to clinical trials and commercialisation.
Frequently Asked Questions
1. What is MedBraid Regulatory Consulting and why is it important for market entry?
MedBraid Regulatory Consulting supports manufacturers in understanding and applying regulatory requirements across development, validation, and commercialization. It helps ensure that sterilization strategies, documentation, and lifecycle controls meet current regulatory expectations for market access.
2. Why are regulators expecting more than test results and certificates?
Regulatory authorities now expect manufacturers to demonstrate ownership of their processes and decisions. This includes justified validation strategies, clear worst-case rationales, and traceable documentation showing that regulatory knowledge is embedded within the organization.
3. How does MedBraid support sterilization strategy and validation?
MedBraid provides expert guidance on selecting sterilization methods, defining validation protocols, and establishing worst-case configurations. This support ensures that EO or steam sterilization processes are scientifically justified, compliant, and suitable for regulatory review.
4. When should manufacturers involve regulatory consulting services?
Regulatory consulting is valuable from early development through routine commercial production. Early involvement reduces the risk of late-stage nonconformities, while ongoing support helps manage changes, scale-up, and evolving regulatory requirements.
5. How does Medistri integrate MedBraid consulting with operational execution?
Medistri integrates MedBraid consulting with in-house sterilization, laboratory testing, and validation services. This approach aligns regulatory strategy with real industrial processes, supporting audit readiness, consistent compliance, and long-term regulatory confidence across the product lifecycle.