stephen Hawking nian cont arp ocean teas Zoteee VALIDATION AND VERIFICATION Rueemitanans sees Beers = =e Ta ca ony na gd se stp one nt nea eee teen cee ‘eer gerenee Sor Boerne . a Soa eisnaroastee: eR = aoe Se Bee egeoneremameseenennam = SSS 510k is premarket notification PMA (premarket approval) Device Development Map ‘Theta Deve Produ Develomertand Muang Map + Most intense oie process —— a oe oe es nn = er = eee HOE Humanitarian Device ExemgtionMEDICAL DEVICES CLASSIFICATION wenn neve BASIC STEPS 10 —— aT Se ECS cn won sangunoratvanin “7 °*SEPESHPLaNcE Wasmanocoecnee i eure See ection Qrrerinnnteyntinimen —* tn te Cnet Sica Statement Guy SpteninanpioneibNSOmAS Salsa ia SERRE rocmmamastacmrearenyl etree am ' : eee eee TTT ' CLASSIFICATION orice arse ——— imeem. : vm ave Noted Body sult your QB 59 pe xnty em pero deeoment a, es cs ae os SSS = : mS a os body contacted by devi (rater. | caer ee oe eesscemreiecs | ee SS 2%) Vestn apes —————— sesmtat ees scenery aaa ae — =r LARATION OF CONFORMITY | oeren ieee TECHNICAL FILE "NICAL FILE TEDESIGN DOSSIER PREPARATION ICAL DATA REQUIREMENTS. ANOCE MARKING ST EE Cntr you mya Margo yair Laseuneanpanausce = aly PROCESSTUMELIN RQUIREMENTS Acree a fF Ekcioumes orcs + POST-MARKET SURVEILLANCE (PMs) A ee ‘AND VIGILANCE Brome sor Boby {aramid Fallowingappactmentofyaur EC REF, our quality stem and mi ae TehnslfieDengn Cone most be ted by Noted Boy ae UpanSicertlcrmplation four scythe Neti Body - " 5 ‘cue onnnee‘Aecciton rte Ateneo ei etomentatin AA) remaster vee Reamer, nt Sbien* le: ott manne Sec, manger, aL sleet eee Path nr her siget ye of ice maine aaton eee ty OA Bart Sop (OMA) the SONS oes ‘enna psn er oboe tanec of Ch inSain ‘att of Becca an Seo Eeginer| EEE) fete EEE ws bt iota iin da esto an ran oata™ ‘eons sown ta oer wants Dopamine ‘nnn ats of ty Fle: WM ion mt fen nisl ae a tai of ig ens platen of sro esha gen fn aes ese ‘mon peer beat mprmere ops spate omesonse ok ona ray as hae Moh Ch dees cure» PUAdppntr er mntng seo ‘ppt ec sa ps ataatos abe hed osu aero Dua Se ft tseamendment seas sts reqre cles HSA Pincay or dees whut estes ‘eeustonin eit hinge eneep om Formdealcenecs sce Sao esse the Cee for Bolton. eer CEH ees {Mhmson: cox earten bond-atee pedir use bet Hadad eal evs So RE SBN Ai torn cs ninety onary co a ron oh spenion Manure so peer uty cor sat apt bee ena 16 Niven suds cee meer tng nk ter ts, wieder er protease Saami cecencrton mreW h semton aoe ster nea rape {oA foot n eton ‘ie enti pcg tte ath ama ey, ny. sy a eee preg TT oan wipe poe nea es yee ee ‘ioscan hgh oo ty cet oC nd ee PA vig te ar nano ty cane nc ro at amen "EDR Ctr fr ns a Ral Han le: repent pacing and ety he pe eth Fo and bg amiatton FON 107 Dames Engg Soy Mee anes pp wit pte reins rama bese Siento ones aempon oe) [CFR Pa 2" renting pee of eo oe, Sues wih scan rk ees ee FOA neato ei oe) por ‘Sel ar reneenpte monsnany,prorance ed ns thean ore «tasty pe eplton 05 epltin 23 Rar 20 feta an rey aes Seago ear we apn, mse aan Sn rans ote een a eno devacenen nate he esscins ene MIMBE(TaAnercan sts or Maes aa Boge Enaneeng) 1. ati Doves Rearing 2 FR Pa t+ ‘ie Aas main ne pte ahi rt aby ge nrg Ince cng deat seus rycen malncons must be ep Wo FOR une he General Controls ‘excl re reat nant ante he FOBC Ae dr abso, {50,58 5 dso. Gener eres appa eel een a np ymplatine fade emp rom ne ft ener ante ch npn uti be dscton eatin otha ee ercampl th custo rion or anal tah 2 FR 7a ae he Spin conte ae etry reuret fr cds eis FDA dasiint de eral obras sented cern tonne ‘sents orion ofp dens ela pr and dev ag meme ie (08) Rg gies ees oto tie Ream + 50: Recods nd repotson dvs + 520 Gene proviso epsing conte of devices intended or aman we Adverse event port Device tcking Unique deve ientictian ten © Reports removal a correctons © Restid evce Good manutacuring practi eiements © samp fr vies for investationa use “Anetanum ta detect and eect obiens ina rly mane veal complanee wth hee reply reqitemens cl er manufactures seme the ety ‘Special Controls devi whih eer conto alone annie opovde nonale asane fhe ‘yan fectvenes ofthe devi, and or wh here ice nfrmation saith special contosto prove sch assrance ‘Special contre sly devi spect nd inde: + Peformance stndards + Postar suns + Pat reites + Special ating eqiements + Prenat data oun + Galan ‘The FA's ertr for Denes and Rasoogil Heath (CORK) oversees he regulation of medical dvies and adation- emitingeectons products nthe United states. Mekal devices are classiest Css and wth eeultory ontelnreasing fom cast CsI The ey equator equrements for manufactures of medial eevcsin the US. inclu extabisnmentregstation, medial device litng rematket nation SIO) oF prematet approval (Pid), vestintiona deve exemption Df for ena! tues, unity sytem (4S) regulon, labeling compane, and medical device reporting (MOR) 1sEsablshment Repsration (2 FR Part 07}** “Manufacturers oth domes ad foreign us register her establishments with the FA. Amal vercation of egitration equa ad foreign manufactrers mat designate a US. AGS. 2 Mies Devs isting (21 CFR Pr 807) Manufacturers, contract manufactures, teres, reoackages,elabelers, and thers mes ist ther devees with US manuloturets of "export nly devices are ako reat ols ther devs. 45 **PremarktNotteabon B10) (24 CFR Prt 807 Subpart Eh ences may require 3510 submission, demonstrating substatal equivalence toa legally dtrbited device ‘On October 26, 2002 the Meal Device Use Fee and Moderation Act of 2002 becameaw le authors FOR to charge fee for medical device Premaret Notation SL reveus Ifyou plan to send » SINK apleation to FDA fora lass or Cli I device, you may fir SIE review by an Aecrted Prsons benef FOR acredted 12 ogmnietons 9 cont 3 primary rele of 670 type of Seve. By law, FOA must ise 2 fal determination within 30 days after receng 3 recommandstion from an AecredtedStep 1: How to Classify Your Device? 510(k) Submission isso [ee Speieonne | SHON rasa atet | Freritn vernomanena | Soctitominn | PPE evans sing. ed limerger mn 14 1 EUmedica device Regulatory Pathway ern European CE Marking Crit Step 4: Regulatory controls dsleciinilemi) er oats Certainly! The CE conformity marking process for medica devices the European Union follows 3 systematic approach, Here's a general overview that incorporates steps applicable tal classes of medical deve | Common Steps for Al lasses 4. Determine Device Classcation:** “classy the medical device according tothe European Medical Device Regulation (MOR) orn Vitro Diagnostic Regulation (VOR). Casity a Class I, orl based on risk 2. "Appoint Authorized Representative (f applicable} Ifthe manufacturers located outside the European Union, appolat an Authorized Representative within the €u, 3. *Fimplement a Qualty Management system (QMS):** Establish and maintain @ GMS that complies with the requeements of the MOR or VOR, 4. **Techncal Documentation:** Prepare comprehensive technical documentation demonstrating canfority with the escent 5. Create Dedaration of Conformity (00C:"* Generate a Declaration of Contarmity declaring thatthe device complies wth relevant EU regulations. Thisithe CE marking onthe deve or package. ang complance with EU regulations tol tps for Cs yo Denes. onary asessnet** ‘Under the apport onbmity ssessnent procedure bad on he dee casteston THs ray ie Noses Boy enaerent lr ls Bond i Seve Maran a comprehense Tech fle contanng al eevant documentation an records scat (Garena rere the ate nomen Note oy throught he enemy 10. "Peote Soety Update Reports PSUR "= Sits Pv ny Upte Repu to Competent thors, proud onging safety sd prtormane intrmstin orcas ei, FF commen Pst are Ss: Certainly Me FDA regulatory pathway for medal devices, 1. *"Determine Device Cassieation assy the medical deve into Cis 2. *Estabishment Registration and sting Manufacturers domestic and foreign) must ester thelr etalshments withthe FOA and Ist thelr devices, Annual vertiation i requied 3. "U.S. Agent Designation for Foreign Manufacturers ** "Foteign manufacturers must designate aUS. Agent. 4. *Quatty system Regulation (OSR)Compiance:=> implement and maintain a Gualty Management system (QMS) ia compliance with 21 CR Part, 820 05H) 5 *"Labling Compliance Ensure that the device labeling complies with 21 CFR Part 8%, This incudes labels onthe sevice itsel and accompanying erature, {6 Mil Device Reporting (MOR) "> here to Medial Devos Reporting requirements ia 21. CFR Fa 803, Report incdens where the device may have cued of contributed to desth or serous nur along with cetain rations 8 Actonal Steps for Clas eves: based onthe asocted rk [pint pale agg cmp eee i wee ction ‘uhstncet digs eogme as + Whore metal deve? Ana deity iinet apap, eile oe {ty emer wd br ego Pah ede eee ne ae rete drat fre eco eee Dees ree ‘RUS ee DvD) nd vs ages se Ses eet Siopeeat Scpusrent elope = Tay =—s, implores pesmait seven tem fo mentor ander dee peromanc, dese 52 oee epoing== Composers ign repring nn the promt eporig eins late nd sya actors Conte sahoren ‘Soninporant te hth oa con dsb todterne the dvs daifeaton an erty he opi eps ene wth tie Seo fry eat, ipl an sin “tetra nt ste wth competent Abort esi compliance ad kt ‘Montreuil bat eat pits inh rely nd nig Srna soe on pronse vase sate Praga Charan Pe Cetin! The FDA regulatory pata or mesial devices, 2. **EtalishmentRepistation and Using"? Manufcturrs [domes ara foreign) mus git he etablshments with the FOA nit thet dees, Annual verison freed 3.7. Agent Designation fr Foreign Manulatres}** Foreign manufacturer mut desgnate US get. Quali System Regulation (SR) Compance: Implement ana mamtain sity Mangement System [OMS] a compliance with 21.7 sioyas 5-*"LabelingComplance:=* Ensure thatthe device aeling complies with 24 CFR Pat 01. This nudes labels onthe dove te and accompanying Mestre ("Medal Deve Reporting (MOR Adhere to Rede! Device Reporting requterents in 21 CFR Fat 803. Repotinidnts where ‘the dence may have cused or contributed oso or serous ry, long with cera 1h sonal steps for Clas Devices: + aren dn pra: Core ein ee soe serial an neg dng i ‘een dei pe ao td kof Sa >. a se ero = Miawsteduomn nations Gan)! Somes + poetmted iets ML Sec ee a Eee Sl ‘Sec ode ang ar maps ay an mamta + Rik manafomet Desig al es ge ss snow be dv, Tis Sr sang ptm he inating trey ad pling eons Rk mgennt shad be agony pes sin develope «anki: Diy oneal for eda rns Dg ho comer tr a, ee ‘srs nmr ay tg sd areata a es + Munters’ Desr sw cones mining proce ny inthe di ae Thi inn sc propa ists epg oo nb wes bi ise heebos development Vato vii soll ita in design oes ‘histo eheting nse i dag lpm a uae aon on ‘Coin Go ese grace nie mingle acne dso ‘stim uhm loi on pci eng oc