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

This depends on the part required and its complexity. A drawing would always be preferable, however, in some circumstances it may be necessary for us to create one and provide it to you for approval.

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.


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.


  • 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 is owned by PolarSeal®. We ask the customer to contribute towards the cost at the beginning of a project, there after PolarSeal® look after the tool and maintain it. If we need to sharpen or replace the tool due to its lifespan, PolarSeal® pays for it.
This depends on the part required and its complexity. Exact delivery times will be provided to you by the Project Manager at time of order.

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.


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.


PolarSeal® Tapes and Conversions Ltd
Guildford Road Trading Estate


PolarSeal® Tapes and Conversions Ltd
Carlton House
34-36 Carlton Park Industrial Estate
IP17 2NL

You can pay by Credit Account, Pro Forma by BACS.

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.

Our standard credit terms are 30 days from end of month.

Get in touch

Send us an email to discuss your project requirements in more detail or book a 1-on-1 video call with a member of the team on a day and time that suits you best using the calendar booking system.

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