Synergy Design Solutions is an ISO 13485 certified company.
ISO 13485 is a quality system standard designed for medical device companies.
The ISO 13485 standard has many of the same requirements as ISO 9001, however, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.
At Synergy Design Solutions, our commitment to quality aligns directly with our business strategy to deliver consistent reliable services and products to our clients.
Synergy Design Solutions is perfectly placed to address the increased product complexity and quality demands facing companies today.
Using an integrated approach, we strive to understand the dynamic challenges faced by you, our client, and work diligently towards meeting your needs. Our services span innovative early stage concepts through to system level design, manufacturing and ongoing customer support.
This part of the process begins with a comprehensive understanding of the relevant client requirements. It then extends to exploratory activities as various potential solutions are considered and discussed.
Solutions ultimately need to be based on an achievable idea and fit within budget constraints. During this phase key risks to the conceptual design are considered with the assistance of rudimentary physical models and engineering experience. Client requirements maybe revisited at this stage to align cost constraints with practical outcomes.
This is a significant milestone involving key design decisions that have critical impact on the final product. The detailed design process incorporates activities to determine exact dimensions, clearances, tolerances, and criteria specific to the actual product or system including environments of use, maintenance access, material properties and packaging considerations.
Production planning is directly related to demand volumes, warehousing capacity, safety stock levels and transport requirements. The most practical manufacturing solution needs to be defined at this final stage to balance budget, quality, lead-time, deliverables and ongoing customer support.
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Synergy Design Solutions Pte Ltd
10 Raeburn Park, #02-08 Singapore 088702