PMS & PMCF with MDR Compliance WarrantyAre you suffering from an increasing number of post-market requirements in the European market? You don’t know how to handle all of this in the future? We have a solution for you. Our experience shows that PMS & PMCF activities can be analysed, remediated or even outsourced in an easy and effective way.
That is why we developed multiple solutions with a focus on class I up to class IIb devices. All are tailored to your needs, giving you the most value out of your post market data.
Newcomer in MedtechYou are excited? You want to enter into this innovative high-tech business? You want to find your way and overcome the regulatory hurdles? You are in need of a time and cost estimate and a realistic roadmap? …And on top of all that, just to make it fun, you have to urgently elaborate a business plan to convince investors? To be successful, you need the right partner, endowed with enough strategic and practical expertise.
We have developed different packages that are tailored to the real needs of MedTech start-ups and any newcomers dealing with medical devices and in-vitro diagnostics.
Plan B @ EAR: Safe EC-REP Solution for SWISS SMEsSwiss manufacturers must prepare for the scenario of having to appoint an EU representative or European Authorised Representative (EAR) in the future. We have put together a package of services that increases the security for SMEs without their own subsidiary in the EU area to maintain the ability to deliver to the EU area and helps to minimize the financial and contractual risks.
Support Regulatory AffairsEach market still requests its specific requirements for registrations of a medical device. Our experience in Europe, North- and South America, Asia as well as the Middle East enables us to support you in an efficient obtaining of the aspired market release.
RA-Intelligence - Relieves Your OrganizationISS maintains a very well developed knowledge management. This makes it possible to create RA Intelligence tailored to your company and to make your RA processes and ultimately your company more efficient and cost-effective. The various elements ensure that you have a better grip on RA issues and that your staff is adequately trained.
Clinical ServicesClinical Investigations run by ISS AG are taking into account the strategic objectives of our customers as well as operational, ethical, regulatory and statistical requirements. We offer a value for our customers from a first draft design to the final clinical investigation report. Clinical Investigations include Feasibility or Pilot Investigations, Confirmatory Clinical Investigations for CE certification or Post Market Investigations.
Post Market Clinical Follow-Up Studies (PMCF)Under the new Medical Device Regulation (MDR) and new Guidelines more often own PMCF-studies to confirm the safety and effectiveness of a medical device are requested by Notified Bodies. The ISS AG is an audited Clinical Research Organization (CRO), which has successfully carried out PMCF-studies.
Clinical Evaluations according to MEDDEV 2.7/1 Rev. 4Through our support you win time and assurance in your clinical evaluations. In addition, our process for the creation of a clinical evaluation offers you several options when defining the scope of work.
Medical WritingMedical Writing is gaining more and more importance for the medical device industry. Combining engineering with medico-scientific knowledge is key for creation of meaningful submission documents and publications Integrated Scientific Services (ISS AG) has decades of cumulative technical and scientific experience in providing supportive services to companies. ISS can help drive the writing of scientific documents in a highly efficient manner to maintain deadlines and budget constraints.
Qualitymanagement ServicesSet-up and maintenance of a quality management system according to ISO 13485 / QSR is an indispensable condition to be active in the medtech sector. We support you in all important steps of a (re-)registration or adjustments of your QMS to new requirements and offer comprehensive consulting services.
Qualification and Validation according to ISO 13485 and cGMPMedical Technology: Qualification and Validation according to ISO 13485 and cGMP – Protocol development, DQ, IQ OQ PQ, statistical methods and tools, Reports.
Engineering SupportWith our experience and knowledge we help you to create and validate your processes according to the regulations by ISO and GMP and to additionally reduce time and costs.