Regulatory authorities are now more watchful of Medical Device industry than ever before resulting in warning letters, 483's. or even observations which can effect your companies reputation and having licences revoked.

Simplimedica  Ltd. is experienced in ensuring you achieve satisfactory audits,   whether you are submitting a 510K application or maintaining your validation system. Simplimedica Validation consultants are experienced  in assisting start up scale  businesses   as  well  as  multinational businesses.

You can hire our services, whether it is initial risk assessment through to advice on validations,  or performing  qualification  at Installation,  Operation  or Performance,  or  perhaps  full  project  management   from  the initial stages of equipment purchase through  to  commissioning   and  handover  to  production.

You may want us to give you training or provide you with templates so that you may perform your own validations, just pay and download. Either way Simplimedica Validations can help you on your regulatory journey.

Contact us for a confidential conversation or a no obligation quote:

Simplimedica Ltd

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Simplimedica Ltd

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