Specialties

Healthcare & Medical Devices

Capabilities

Accord maintains state-of-the-art medical manufacturing facilities and operates against stringent standard operating procedures (SOPs), quality checks and traceability requirements required by our customers and medical certification.

Track Record

Supported by decades of healthcare manufacturing experience for Tier 1 OEMs, Accord has a proven track record in the production of quality-critical medical products, delivered on-time straight to the door of our customers.

Certification

Accord maintains several industry certifications critical to the needs of the global healthcare manufacturing industry, including ISO:13485 for medical devices, FDA certification for various medical products and finished goods and ISO:15001 compliant facilities for ultrasonic cleaning.

Decades Of Healthcare Manufacturing Experience

Accord maintains a flagship focus on serving the global healthcare & medical devices industry across the design, manufacturing and assembly of complex, quality-centric parts and products. This is supported by decades experience and multiple tier 1 OEM healthcare customers, many having been with Accord for more than a decade.

 

Accord’s in-house capabilities, machinery, facilities and suite of industry leading certifications are expertly aligned to the needs of the global healthcare industry and our customers. Accord employs a number of healthcare SMEs across its production facilities, business and QA functions, providing critical industry-specific insight.

Dedicated Healthcare Facilities

Accord maintains a number of purpose-built facilities to serve its healthcare client base, including dedicated medical and ultrasonic cleaning facilities and secluded, ISO:15001 compliant controlled working environments. Accord also operates a series of standard operating procedures (SOPs) and quality checks aligned with the medical industry, and in many cases creates customised processes to align with the documentation used or required by the customer.

Best-in-class Medical Certification

Accord’s suite of industry certifications enables it to manufacture almost any medical product, to any specification. This extends, but is not limited to:

 

  • ISO:13485 (Medical Devices).
  • FDA Certification (Medical & Healthcare Products)
  • ISO:15001 Compliance (Anesthetic & Respiratory Equipment)
  • ISO:9001 (Quality Management)
  • ISO:14001 (Environmental Management)
  • REACH & RoHS (EU product regulations)
  • CE (EU product markets)

 

This certification has allowed Accord to design, manufacture and assemble millions of high-value medical products to date including complex medical insufflators, healthcare consumables, surgical equipment, breathing apparatuses and much, much more.

Our Process

1

We operate on a project-by-project basis, and work collaboratively with our clients on all design engagements. All project files, scope documents and design details are available online, providing customers with a ‘live’ feed to monitor project progress and comment freely.

2

We take preliminary concepts from 2D drawings or 3D models through an iterative design process, selecting the appropriate design software and project management methodology to drive the engagement.

3

All products must then go through a rigorous testing cycle before the final prototyping and validation phase. Only when the finished product is perfect, all items agreed in our initial scope assessment are complete and all parties are happy can final designs be signed off.

OUR CERTIFICATION & QUALITY PLEDGE

At Accord, the quality of our products are our greatest priority.