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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

Medical Device Regulatory

Let Us Help You 

Guiding you through all of the complex Medical Devices regulatory affairs.

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