Tissuemed Business Post-Brexit: European Continuity Secure
Following the recent departure of the UK from the European Union, the Tissuemed business has taken all measures possible to ensure that it maintains its commercial relationships within the EU.
In short, the first priority was to ensure that Tissuemed products comply with the European regulations. To this end, in November 2020, Tissuemed appointed mdc, Germany as its new European Notifying Body. We subsequently secured the recertification of EN ISO 13485 Quality Management System and EC Design Examination Certification for the TissuePatch™ family of products.
Managing Director, Peter Maver announced in December 2020 that the company had appointed Obelis s.a as its European Authorised representative. This means it has fulfilled the essential requirements in accordance with article 14.2 of MDD 93/42/EEC.
Peter commented; “We are delighted that we’re able to retain our relationships with distribution partners in key European markets. We’re greatly looking forward to the continued expansion of our business within the European Union.”
Tissuemed in China
The Tissuemed business has secured recertification and upgrade of its TissuePatchSF™ brand in China for the next 5 years. This means excellent prospects for the Tissuemed business in the region.
The growth opportunities for Tissuemed products in China remain extremely positive. Consequently we look forward to the continued expansion of our customer base and improving the recovery of patients across the country.
Peter Maver states; “We are opening a second cleanroom early in the New Year, so we are well positioned to ramp up production. As a result the Tissuemed business will be able to cater for a growing business. That means not only in China, but throughout the world.”
UK Distributor Appointed: Delta Surgical Ltd.
Tissuemed has partnered with Delta Surgical Ltd. in the UK.
Tissuemed is increasing its focus on product and clinical development, so has elected to change to a distributor model in the UK. As well as allowing the company to commit its resources to R&D, this move is intended to enhance service levels for customers.
Delta Surgical currently supplies a large and complimentary portfolio of products. Celebrating its 20th anniversary next year the company is well established in the UK. Firstly it is well known for providing innovative products. Secondly customers can be assured of excellent service from Delta’s professional sales team.
As of the 1st of October 2020, Delta Surgical took full responsibility for clinical and customer support for the TissuePatch™ product family (TissuePatch™ and TissuePatchDural™) throughout the UK.
Peter Maver commented; “These changes are all good news for the Tissuemed business. As a result we’re delighted to be able to expand our commercial opportunities and our manufacturing capability in parallel.