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Regulatory and Quality Support for Medical Devices

Regulatory
Strategy

Regulatory submission

QMS
Support

On going consulting

Reunión de negocios
Medical device quality consulting
Medical device regulatory consulting
ISO 13485 medical device consulting

Quality & Regulatory consulting

We develop a specific plan for each manufacturer of medical device, machinery, cosmetic and nutraceutical, in order to provide the most efficient Authorized Representative and Import services. By positioning ourselves in the market, we make our clients stand out and be competitive in a world of dynamic regulations. We design regulatory and fundraising strategies, in conjunction with representation and importation.

However, we also adapt to customers and provide non-comprehensive services, such as the Authorized Representative service without importation, or only regulatory consulting. We have the knowledge, smart tools, and global resources to understand the implications of the decisions our clients make. Contact us to find out how this service can benefit you.

Obtain your CE certification now!

We advise on ISO 13485, 14971 and EU MDR QMS (MDR Quality System Management)

QMS compliance

AF Pharma helps you with your QMS

QMS Compliance

Welcome to AF Pharma Consultancy, your reliable partner in navigating the complex world of Quality Management System (QMS) and ISO 13485 compliance for the medical device industry. With our expertise and dedication, we help medical device manufacturers streamline their processes and achieve the highest standards of quality and regulatory compliance.

 

QMS Benefits 

- Comprehensive QMS Solutions:

We offer end-to-end solutions tailored to your specific needs, starting from medical device QMS design and implementation to ongoing maintenance and improvement. Our experts ensure that your QMS aligns with ISO 13485 requirements, enabling you to meet regulatory standards effortlessly.

- ISO 13485 Certification Support:

We understand the importance of ISO 13485 certification for your medical device business success. Our consultants will guide you through the certification process, assisting with documentation, internal audits, and readiness assessments. We will work closely with your team to ensure a smooth transition and successful certification.

- Regulatory Compliance Expertise:

Navigating the ever-evolving landscape of medical device regulations can be overwhelming. Our consultants stay up to date with the latest regulatory changes and industry best practices, ensuring that your QMS remains compliant with all relevant regulations, including FDA, CE, and other global requirements.

- Proven Track Record:

With years of experience serving clients in the medical device industry, we have a proven track record of delivering exceptional results. Our satisfied clients attest to our commitment to excellence and our ability to drive success through effective QMS implementation and ISO 13485 compliance.


Ready to elevate your QMS and achieve ISO 13485 certification with confidence?

Contact AF Pharma Consultancy today to schedule a consultation. Let us be your trusted partner in optimizing your processes, ensuring regulatory compliance, and positioning your medical device business for long-term success.

We provide regulatory and quality suport for medical devices, through our consultants, or partner consultants, to help them achieve their objectives.
 
Contact us for more information and to provide you with the necessary service for your business.

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