Our Services

Our consultancy services range from design, implementation and maintenance of quality management systems, preparation of technical files for regulatory approvals, part-time and interim management support, auditing both internal and external, management reviews and presentations, training and mentoring.

The general services we provide include:
Regulatory Affairs: Preparing CE Mark, FDA and International Regulatory Submissions; 
Medical Device Vigilance and Reporting Systems
Regulatory inspection Gap Analysis
Site / Company Representative for Regulatory Inspections
Clinical Trial / Performance Evaluation Advice and Guidance including clinical strategy, protocol design, IRB/ IEC submissions, Competent Authority submissions for your Clinical Trial and Clinical Study Report Writing Services
Quality System / QMS requirements
Quality System Design, Implementation and maintenance to ISO 9001, ISO 13485 and QSR’s (PART 820)
GMP and FDA Compliance
Validation of Equipment, Processes, Test Methods, Facilities, Product Software
Process Mapping of your Quality System and related systems
Business and Computer Systems validation incl. compliance to Part 11 And Electronic Records &  Signatures
Management Review
QMS gap analysis and remediation
Design Control (New Product Development)
Technical File / Design Dossier
Technical and Design File Reviews
Product Classification
Clinical Evaluation Reports
Biological safety evaluations
Risk Management
Risk Management (ISO 14971)
Providing a risk-based approach to meeting our Quality and Regulatory needs
Internal and External Auditing
Supplier Approval and Audit Program Implementation and Management
Pre-Audit Preparations (FDA, MHRA, Notified Body, unannounced)
Post Audit Advice and Guidance
Mock Notified Body / FDA audits
Support Activities
General QA Support / Advice on how to meet ISO 9001, 13485, FDA and EU GxP Requirements ( Documentation, Change Control, Validation, CAPA / Incident Management)
Investor diligence – quality and regulatory due diligence (investor-ready, and also for investors)
Outsourcing Organisation
Training – GMP training with an FDA/MHRA focus

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