Our medical device consultancy services cater to manufacturers, sponsors, and distributors across the Asia Pacific region, assisting them in adhering to the stringent requirements and standards set forth by esteemed organizations like the US FDA CRF 820, ISO 13485 Quality Management System for Medical Devices, and ISO 14971 Risk Management for Medical Devices.

Our seasoned ISO 13485 consultants offer a comprehensive suite of services, ranging from facility design architecture to the formulation of a Quality Management System (QMS) tailored to ISO 13485 standards. Leveraging an extensive portfolio of past projects, we ensure swift and efficient delivery of our services.

We specialize in guiding clients through the intricate process of identifying applicable regulations and achieving compliance without compromising business success.

BioGreen provides consultative support for companies seeking to register their medical devices with the Therapeutic Goods Administration (TGA) for distribution within Australia.

An independent review of your facility design serves as a prudent precautionary measure, ensuring optimal design prior to construction or lease commitment.

We facilitate the sourcing and qualification of overseas manufacturers and suppliers for medical devices, ensuring your supply chain meets the highest standards.

Adhering to the “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of Manufacturer Control of Suppliers” issued by the former GHTF (now IMDRF), we conduct comprehensive audits of your suppliers.

Receiving a deficiency notice post-audit can be daunting. BioGreen assists in preparing effective audit responses, addressing both major and minor issues.

BioGreen boasts a team of consultants with extensive experience as TGA and PIC/S auditors, well-versed in international regulatory codes for medical devices.

We demonstrate the integration of processes like Lean Manufacturing and Six Sigma within the regulatory framework of the medical device industry.

For resource-constrained organizations, we provide skilled and experienced contractors with medical device expertise to support your projects and operations.

BioGreen’s project management services ensure seamless production ramp-up and compliance with industry regulations for medical device projects.

Our validation services encompass cleaning, process, and computer systems validation, offering a comprehensive solution for your validation needs.

We assist in identifying permanent or temporary staff, as well as contractors with specialized technical skills and medical device knowledge.

BioGreen frequently implements ISO 13485 QMS in medical device and IVD companies, ensuring compliance with ISO 13485:2016 and/or FDA QSR 820 standards.

We offer a diverse range of medical device-focused training courses, including ISO 13485 and ISO 14971, delivered online, on-site, or in a city near you.

To learn more about our services, request a quote, or pose any questions, kindly complete our enquiry form here.