Sparko Quality Consulting is fully committed to supporting the provision of outsourced Quality and Regulatory services, across the full spectrum of the product life cycle, within the MedTech, Diagnostic and Biotech space.

As a trusted global partner and proven life-science specialist, SQC prides itself on delivering flexible, bespoke solutions tailored to meet the varying needs of its clients.

Some of our managed services include:
- UKCA & CE Marking 
- Validation Lifecycle
- EU MDR & IVDR transition
- UK Responsible Person (UKRP)
- FDA Regulatory submissions; 510(k), De Novo, PMA
- CER/ PER Authoring 
- Regulatory Strategy 
- ISO 13485/ ISO 9001 QMS development and maintenance 
- GCP, GMP, GDP, GVP Audits

View the full extent of our services on our website.

SQC

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SQC

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