Solving challenges within a high-reliability manufacturing environment
Don’t settle for less
…in terms of products entering the market, complexity in concept, creation, customisation, and commerce and of course certification and compliance.
Thanks to our unique experience, we are in an individual position to harness the power of our knowledge network to enable innovation and connect our customers to technology, all within our high-reliability manufacturing environment to solve the individual challenges that the medical market presents.
In this customer case study, one of our valued medical customers, Sanandco describe the product realisation challenges that they faced, which encouraged them to reach out to us at SMS – Smart Made Simple for product concept, creation, and commercialisation.
‘MonitorMe from Sanandco is an intelligent landline telephone that captures vital signs from remote locations. It makes possible earlier hospital discharge and introduces a new way to provide long term care of the elderly.’
We developed a wide medical device product portfolio touching the complete production lifecycle from concept through to the consumer.
Ever mindful of the stringent regulatory compliance demanded by the healthcare industry, our engineering teams support customer products through their complete life-cycle. Our quality standard is backed up by ISO 13485, which is recognised around the world, as the leading standard for the medical industry.
We are asked about our medical device manufacturing capabilities:
What certification do you need to manufacture a medical device that is non-intrusive?
ISO13485:2016 is the new updated International Standard, that defines the requirements of a Quality Management System that is used to ensure that a Medical Device is manufactured, tested, and assembled to the applicable customer and regulatory requirements.
ISO13485:2016 is used by the Legal Manufacturer (Design Authority) to help evidence that the product is manufactured to the applicable regulatory requirements, as part of their Technical File for CE Marking.
SMS – Smart Made Simple holds this accreditation
Is SMS – Smart Made Simple Certified to ISO 13485 standards?
SMS Electronics Ltd are Certified by BSI to this standard and hold Certificate Number: MD 585587 (Alongside a BSI issued Certificate for ISO9001:2015 – FM 75149).
At present, we have four to five customers that our certification supports. Sanandco are one of these, read their story here
What does ISO 13485 certify and why do you need it?
Certification against ISO13485:2016, is used to confirm that the Quality Management System in place at the Certified Organisation, meets the requirements of the standard.
It certifies that we have processes that can control, manage and deliver a medical grade product within our production facility at SMS – Smart Made Simple.
It is required to ensure we have a robust process, in place to support our supply chain and manufacturing operations. It validates that that are repeatable and controlled at every stage.
What do I need to consider when manufacturing a medical device?
The main points to consider when manufacturing a Medical Device, are as follows:
- What are the applicable regulatory requirements that are associated with the product being manufactured?
- Which parts of the Medical Device Directive are applicable?
- What classification of Medical Device is the product?
- What conformity assessment module is applicable to the product?
- Who will act as the “Notified Body” for the Medical Device?
- Compile your “Technical File”, in order for the product to be “CE” marked.
- Is the Organisation who will be assembling the product, certified to ISO13485:2016?
How important is Design for Compliance?
Design for Compliance is fundamental when designing a Medical Device product.
The design, and the manufacturing processes required to assemble such a product, need to take in to account the applicable regulatory requirements.
Having a full understanding of the medical sector is extremely important to ensure to capture all elements that are required and equally don’t spend too much time on areas that are not. It’s Smart Made Simple.