Screen­tec earns approval from their esteemed FDA-reg­u­lat­ed cus­tomer

Screen­tec Oy has shared a remark­able mile­stone in the com­pa­ny’s jour­ney and announced earn­ing approval from their esteemed FDA-reg­u­lat­ed cus­tomer after a suc­cess­ful audit.

This approval marks a sig­nif­i­cant accom­plish­ment for the com­pa­ny, offi­cial­ly estab­lish­ing Screen­tec as a trust­ed man­u­fac­tur­er of their prod­uct. It not only unlocks new growth oppor­tu­ni­ties but also rein­forces Screentec’s posi­tion in the indus­try.

‘The audit result is not only a tes­ta­ment to our com­mit­ment to qual­i­ty but also a sig­nif­i­cant step for­ward for Screen­tec. This achieve­ment posi­tions us as a reli­able part­ner for clients seek­ing FDA-com­pli­ant man­u­fac­tur­ing, there­by enhanc­ing our com­pet­i­tive­ness in the glob­al mar­ket­place,’ said Antti Tau­ri­ainen, CEO of Screen­tec Oy.

Spe­cial recog­ni­tion goes to the com­pa­ny’s excep­tion­al team, whose effort and hard work made this achieve­ment pos­si­ble:

• Jaana Kana­nen (Qual­i­ty Man­ag­er)
• Kat­ja Lehtomaa (HR and Project Man­ag­er)
• Hamza Khal­lok (Process Qual­i­ty Engi­neer)
• Jani Suti­nen (Process Engi­neer)
• Mia-Maria Kivelä (Qual­i­ty Assur­ance Engi­neer)
• Mikko Paakkolan­vaara (CTO)
• Jus­si Saukko (Design Depart­ment Man­ag­er)
• Petri Huhti (Pro­duc­tion Man­ag­er)

The Impor­tance of Ver­i­fi­ca­tion and Val­i­da­tion

‘The jour­ney towards FDA reg­u­la­to­ry require­ment com­pli­ance high­lights the crit­i­cal role of V&V in ensur­ing prod­uct qual­i­ty and reg­u­la­to­ry com­pli­ance. By care­ful­ly ver­i­fy­ing and val­i­dat­ing our process­es, we ensure that the prod­ucts meet reg­u­la­to­ry stan­dards, guar­an­tee­ing their safe­ty, effi­ca­cy, and reli­a­bil­i­ty for the end-users,’ adds Tau­ri­ainen.

Source: Screen­tec Oy