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H1 - Supporting you with all things Medical Device Consulting
Regulatory Service
H1 - 20-70 characters and to include keyword
If you're in the process of developing a medical technology or combination product, we can help you with every aspect of its development.
From advising you on which products fall under what classifications to ensuring that these products make it through all necessary approvals, we'll have your back throughout this whole journey.
We know exactly how to navigate all different regulatory systems no matter where they are located - so if your product needs approval for US markets, European markets, or somewhere else altogether, then let us take care of it for you.
Support
Our team will guide you through the complicated and highly regulated process
Management Reviews
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Cost of Quality
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Training Management
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Non-conformity / CAPA Management
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Vigilance
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Statistical Analysis
From process control to measurement system analysis and product performance.
Complaints Management
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Continuous improvement
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Quality system Design
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Supplier Management
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Process Quality
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Risk Management
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
Product Realisation
Bespoke Quality system Implementation and service to ISO 13485 and 21 CFR PART 11
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