Medical Device
Regulatory Affairs
Services
MEDICAL DEVICE – REGULATORY
Regulations can be overwhelming when bringing your medical device to market and staying compliant. That’s where Network Partners can help you navigate your medical device regulatory challenges. We’ve designed our process to provide the right support at the right time – helping our clients deliver products to healthcare providers and patients.
Submission Preparation
Medical Device regulatory affairs experts support global submissions.
- US Regulatory pre-submission and marketing authorization submissions, including internal agency meeting preparation
- EU MDR Technical Documentation
- Health Canada Licensure and Amendments
- International STED development / ROW Registrations / IMDRF Format
Post-Market Regulatory Support
Our team utilizes its medical device industry experience and executes regulatory post-market strategies in a cost-effective and compliant manner.
- Annual Reports
- Change Assessments and Supplements
- MDR Reporting
- Regulatory Agency Support
- FDA-483 and warning letter responses
- Consent decrees
- Recall Strategy and Support
- Liaison between company and regulatory agencies
CERs
- Writing Clinical Evaluation Plans (CEPs)
- Updating existing CERs for compliance with MEDDEV Rev. 4 & EU MDR
- Writing pre-market CERs compliant with MEDDEV Rev. 4 & EU MDR
- Writing Post Market Clinical Follow Up (PMCF) plans
- Clinical evaluators for various therapeutic areas
- State-of-the-art justification
- Literature searches, weighting and summarization
EU MDR/IVDR Support
- Overall EU MDR/IVDR compliance strategy
- Notified Bodies Selection and Transition
- Labeling content review and updates
- Technical documentation gap assessment and remediation
- MDD Design dossiers and renewals leading up to Date of Application
- CER and PER writing and review
- Post-marketing surveillance/follow-up plan development
- Assess and verify economic operator responsibilities
Regulatory Strategy Development
Network Partners Experienced Regulatory Project Leads offer a comprehensive approach for developing your regulatory strategy.
- Develop Regulatory strategy and Regulatory Project Plan
- Identify Project deliverables
- Define marketing strategy support through international registration planning
- Provide due diligence for mergers and acquisitions
