Distinct Compliance Engineering company is a leader in offering consulting services to the healthcare industries worldwide. Being in the industry for years, our medical device consultancy has an extensive exposure to help medical device, biotechnology, and pharmaceuticals keep pace with Australian, European, U.S., and Canadian Regulations.

Whether you’re a sponsor, distributor, or manufacturer, our team of highly specialised medical consultants can help you comply with requirements set by ISO 13485 Quality Management Systems, US FDA 21 CFR part 820, and ISO 14971 Risk Management for Medical Devices.

Medical device consultants

With medical device consultancy like ours, you can benefit in the following ways:

  • Ultimate Consultancy Experience: We have a large network of qualified and experienced consultants with continued exposure to the medical industry. Thus, you can always rely on our insightful advice in any case.
  • Experience in Regulations: Our team stay up to date with new requirements for different device compliances and regulations. We believe in teamwork and strive to provide the best customer service.
  • Niche Systems and Processes: We make use of effective methodologies driven from our years of experience to make medical device audits and screening easier.

Medical device Services

We have helped hundreds of distributers, manufacturers, and sponsors around Australia.

ISO Compliance & Standards

ISO comprises a wide range of global standards to help manufacturers, distributors, and sponsors achieve high-end customer satisfaction and product conformance by making use of a quality management system. We have assisted dozens of companies to achieve ISO compliance.

QMS Development and software

Distinct Compliance Engineering is one of the few medical consulting company integrating ISO 13485 QMS (Quality Management Systems) in medical devices with agile software development principles. If you are a software design house looking to branch into medical device, we can help.

Our Contractors

If you’re new to the industry, you might want to take help from experienced and qualified contractors to get the job done. If so, we’ve got you covered. We offer professional contractors with your required skills and knowledge to aid you in the process.

Medical Device Vendor Management

Are you looking for authentic and quality manufacturers? Contact us and we’ll help you establish a robust vendor management process.

EU Medical Device Regulation

The latest Medical Device Regulations ((EU) 2017/745) are mandatory on May 26, 2020 – superseding the EU’s Medical Device Directive (93/42 EEC). Please contact us and get your medical devices and systems to comply with new EU Regulations.

Device Compliances

We’ve been helping companies get their medical devices compliant with IEC 62304, 62366, 60601 standards. Those who are new, here is a brief discussion on these IEC standards:

  • IEC 62304: Related to software in medical devices.
  • IEC 62366: Related to the interaction of humans with the device and ergonomics.
  • IEC 60601: A suite of standards related to electrical devices. Medical devices with software programs (PEMS) are included in this category.
  • FDA 21 CFR Part 11: a requirement in the US for electronic signatures and records management for software applications.

Get a Quote

Whether you’re after regulatory compliance, medical audits, internal audits, supplier audits, or anything related to IEC standards, feel free to contact us.