Medical Device Manufacturers & Suppliers
With a team of medical device professionals spanning decades of industry experience, Distinct Compliance Engineering can assist you with your medical devices, specialising in active, medical device software, and IVD within all classes to local and international requirements.
Areas that we can help you include;
- ISO 13485 Quality Systems implementation, management and consulting
- 1st and 2nd party audits
- 3rd party audit representation
- IEC 62366 Usability engineering development
- IEC 62304 Software Development Lifecycle methodologies and implementation
- ISO 14971 Risk management consulting and implementation
- IEC 60601 Guidance (General, collateral, and particular standards)
- Test protocols and other technical documentation
- Clinical evaluation consulting
- Validation/verification development and consulting (process/equipment/product)
- Medical Device Regulation Consulting, Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- 21 CFR Parts 11, 820, and FDA determinations 510(k), PMA, De-novo
- TGA medical device conformity assessment pathways
Construction/Civil and Facilities services
Our roots stem into the building and construction sector. Our staff have extensive knowledge various types of construction work from earthmoving, drainage, through to roofing and cladding. Furthermore, our team hold current industry induction cards.
Whether you are project manager, excavation team or a DB/CB-U we have solutions to increase your workflow and further tender appeal including:
- ISO9001/ISO14001/ISO45001 implementation, maintenance, and consulting.
- Management system audits.
- Site audits. We can develop an audit criterion or work with your existing requirements.
- Supplier audits and contractor compliance.
- JSA/SWMS development.
- ISO31000 risk management principals and initiatives.
- 3rd party audit representation on your behalf.
Consumer Electrical and Industrial Equipment Importers
Manufacturers looking to export, and importers bringing goods into the country are faced with a myriad of compliance challenges.
Our team has experience with Australian product approvals and can help develop the technical documentation required to demonstrate compliance.
Works include:
- ISO9001/ISO14001/ISO45001 implementation, maintenance and consulting
- AN/NZS 4417 compliance and regulatory strategies for your goods
- Supplier audits – supplier compliance to internal/external requirements
- ISO31000 risk management principals
- ISO12100 risk and safety for equipment and machinery principals
- EU Machinery Directive consulting
- EU EMC Directive Consulting
- EU Low Voltage Directive Consulting
- CE compliance consulting/Technical file reviews
- ERAC/EESS compliance
- ACMA/EMC compliance
- Test protocols and other technical documentation
- 3D CAD modelling, manufacturing drawing, and visualisation
Engineering Companies, Electronics and Mechanical Manufacturers
In the service industry, standing out from the crowd is paramount to your business. We have developed quality, safety, and environmental management system solutions tailored to various service providers including commercial cleaners, security organisations, transport and logistics providers, as well as design houses - all looking to elevate their businesses to the next level and create client appeal through certification.
We can help with:
- ISO 9001/ISO 14001/ISO 45001/ISO 13485 implementation, maintenance and consulting
- Management system audits
- Site audits - we can develop an audit criterion or work with your existing requirements
- Supplier audits and contractor compliance
- JSA/SWMS development
- ISO31000 risk management
- 3rd party audit representation on your behalf