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Medical Device Consultants

We are medical device consultants. Our focus areas are GMP, CE Mark, UKCA Mark, FDA 510k, ISO 13485, and 21 CFR 820 compliance, and more. We deliver results faster, regardless of the device’s complexity or technology.

FDA 510k Clearance

Why Choose Us as Medical Device Consultants!

As premier medical device consultants, we stand out for several compelling reasons:

 

  • Our team comprises qualified and experienced professionals with extensive knowledge and experience in medical device regulatory requirements.
  • We offer a wide range of services, including CE marking, UKCA Mark, US FDA 510k, ISO 13485, 21 CFR 820 certification, and more, providing end-to-end solutions for our clients.
  • We pride ourselves on delivering results swiftly, ensuring that our client’s projects stay on track and meet their deadlines.
  • Recognizing that every device and client is unique, we provide customized solutions that address specific needs and challenges.
  • With a deep understanding of regulatory landscapes worldwide, we help our clients navigate complex compliance requirements effectively.
  • A client-centric approach is our focus, and we strive to build long-term relationships based on trust, transparency, and exceptional service.
  • Our proven track record of success speaks for itself, with numerous satisfied clients and successful projects under our belt.
  • Our team presence in various countries makes us reach customer locations fast in case of any surprise inspection or any other situation.
  • Office locations in Germany, India, the UK and the USA. Associated offices in Australia, Malaysia, South Korea and Vietnam.
  • We have been in the business since year 1999.

 

Choose us as your medical device consultants, and experience the difference firsthand.

FDA 510k

FDA 510(k) clearance and approval are mandatory for most of the class II and class III medical devices to be sold in the USA.

As premier medical device consultants, we stand out for several compelling reasons:

 

  • Our team comprises qualified and experienced professionals with extensive knowledge and experience in medical device regulatory requirements.
  • We offer a wide range of services, including CE marking, UKCA Mark, US FDA 510k, ISO 13485, 21 CFR 820 certification, and more, providing end-to-end solutions for our clients.
  • We pride ourselves on delivering results swiftly, ensuring that our client’s projects stay on track and meet their deadlines.
  • Recognizing that every device and client is unique, we provide customized solutions that address specific needs and challenges.
  • With a deep understanding of regulatory landscapes worldwide, we help our clients navigate complex compliance requirements effectively.
  • A client-centric approach is our focus, and we strive to build long-term relationships based on trust, transparency, and exceptional service.
  • Our proven track record of success speaks for itself, with numerous satisfied clients and successful projects under our belt.
  • Our team presence in various countries makes us reach customer locations fast in case of any surprise inspection or any other situation.
  • Office locations in Germany, India, the UK and the USA. Associated offices in Australia, Malaysia, South Korea and Vietnam.
  • We have been in the business since year 1999.

 

Choose us as your medical device consultants, and experience the difference firsthand.

MDR and IVDR CE Marking Consultants

Navigating the complex regulatory landscape of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) requires expertise and thorough understanding. Our team of MDR and IVDR consultants is here to guide you through every step of the compliance journey, ensuring your products meet the stringent requirements for CE marking and EU market access.

Here's how our consultancy services can benefit you:

Transition Period: Manufacturers must ensure timely transition to MDR or IVDR compliance, depending on their device classification and the respective regulation's deadlines.

Notified Body Involvement: Engaging with a designated Notified Body is crucial for conducting conformity assessment procedures and obtaining CE marking under MDR or IVDR.

Documentation and Technical File: Manufacturers must maintain comprehensive documentation, including technical documentation and a Declaration of Conformity, to demonstrate compliance with MDR or IVDR requirements.

UKCA Marking

UKCA Mark Consulting helps in the certification process, starting with technical file preparation, testing, and certification body submission.

ISO 13485, 21 CFR 820

Implementing a robust Quality Management System (QMS) is of paramount importance for medical device manufacturers to ensure consistent product quality, compliance with regulations, and patient safety. A well-designed QMS provides a systematic approach to managing processes, resources, and responsibilities throughout the entire product lifecycle.

It helps businesses establish standardized procedures for design, development, manufacturing, testing, and post-market surveillance. By adhering to international standards such as ISO 13485, medical device companies can demonstrate their commitment to meeting the highest quality standards and regulatory requirements.

A robust QMS fosters a culture of continuous improvement, encouraging businesses to monitor and address any deviations or non-conformities promptly, leading to enhanced product reliability and customer satisfaction.