FAQ's - providing clarity for medical device manufacturing
Drawings, prototypes, ordering, and more...
PolarSeal® have compiled a list of frequently asked questions to provide you with clarity around the topics of tooling, delivery, quality assurance, services and more.
Drawings and specifications
Our preferred format is DXF, however, we will accept PDF if it is fully dimensioned. Correct scaling is vital; please check your measurements prior to sending.
This is project dependent, further information will be stipulated by your account manager or project manager. Some examples could be projected annual quantities and target deadlines.
Ordering
This will be dependent on materials and presentation, for instance, slit rolls from stock materials could be with you in 1-2 weeks, whilst rotary converted parts may be 6-8 weeks. In the case of new conversions, we may also need to acquire tooling which may also affect lead time.
Quality
- ISO 13485:2016
- MDD 93/42/EEC – being replaced by regulation 2017/745 in May 2021
- ISO 7 Cleanrooms to 14644-1
- FDA Registered and Audited
PolarSeal® has the quality assurance checks in place to inspect all incoming materials, samples, and finished products. Standard Operating Procedures (SOP’s) are in place to be followed throughout the entire manufacturing process.
An Acceptance Quality Limit inspection is used to assess the overall quality of a batch of goods by a statistically valid sampling method.
Tooling
Approximately 10 meters per tool is required.
Visual quality of the tools is checked on arrival and dimensions are verified once fitted to the machine and first samples are produced.
Our standard lead time for existing products is 6-8 weeks, however, this can vary based material availability and complexity.
General
Monday – Friday 07:00 – 17:00
Manufacturing continues on Saturday through to mid-day.
Yes, material samples for evaluation are available, either from stock or from our suppliers. Stock materials are usually supplied as short length strips of material on our sample card but can be short length rolls or sheets.
Bespoke die-cut samples are available. If possible, a DXF file should be supplied for evaluation.
Yes, we are able to help you with your design; utilise our extensive experience and knowledge to create bespoke parts from conception through to final production.
We can produce prototypes, with soft tooling. Take advantage of our rapid prototyping capabilities. We can also produce prototypes using any of our machines.
Either one of the below addresses can be used depending on the agreed address with your account manager.
Surrey
PolarSeal® Tapes and Conversions Ltd
Guildford Road Trading Estate
Farnham
Surrey
GU9 9PZ
Suffolk
PolarSeal® Tapes and Conversions Ltd
Carlton House
34-36 Carlton Park Industrial Estate
Saxmundham
Suffolk
IP17 2NL
You can complete and submit our credit application form and we can also send pro-forma invoices and receive credit card payments for speed and convenience.