Device Master Record (DMR)

Definition of the term (“What is a Device Master Record?”)

A De­vice Mas­ter Re­cord is a tech­ni­cal pro­duct file with a com­pi­la­ti­on of do­cu­ments and re­cords con­tai­ning all spe­ci­fi­ca­ti­ons and ma­nu­fac­tu­ring pro­ce­du­res for a me­di­cal de­vice(FDA 21 CFR 820). The term De­vice Mas­ter Re­cord was co­in­ed by the US Food and Drug Ad­mi­nis­tra­ti­on (FDA) and is part of the Qua­li­ty Assu­rance Re­gu­la­ti­ons (QSR).

What is the connection to the FDA?

As de­ve­lo­p­ments in the me­di­cal de­vice sec­tion have in­creased enorm­ously in re­cent ye­ars, the re­gu­la­to­ry aut­ho­ri­ties are also con­stant­ly fa­cing new hurd­les. The FDA (Food and Drug Ad­mi­nis­tra­ti­on) has be­co­me an in­ter­na­tio­nal role mo­del with its re­lia­bi­li­ty and con­sis­tent re­gu­la­ti­on. With re­gard to the FDA, the De­vice Mas­ter Re­cord re­pres­ents one aspect of the com­pre­hen­si­ve do­cu­men­ta­ti­on sys­tem ai­med at re­gu­la­ting the qua­li­ty assu­rance of me­di­cal de­vices. While the FDA only fo­cu­ses on de­vices for the US mar­ket, the re­vi­si­on of ISO 13485(: 2016) and the Me­di­cal De­vice File an­cho­red in it now also make qua­li­ty assurance(QA) do­cu­men­ta­ti­on man­da­to­ry in Europe.

What are the components of a DMR?

De­vice specifications:

  • De­tail­ed de­vice de­signs and specifications.
  • Ma­te­ri­al spe­ci­fi­ca­ti­ons.
    Com­po­nent dra­wings and specifications.
  • Pro­duct la­bel and pack­a­ging details.

Ma­nu­fac­tu­ring process:

  • Step-by-step as­sem­bly instructions.
  • Qua­li­ty con­trol pro­ce­du­res.
    Ca­li­bra­ti­on procedure.
  • Test and in­spec­tion protocols.

Qua­li­ty con­trol records:

  • Re­cords of qua­li­ty con­trol tests.
  • Re­ports on de­via­ti­ons and cor­rec­ti­ve measures.
  • Sup­pli­er au­dits (the qua­li­ty ma­nage­ment re­pre­sen­ta­ti­ve of a cus­to­mer au­dits his sup­pli­er) and proofs. 

Re­cords of the de­vice history:

  • Pro­duc­tion re­cords for each batch.
  • Re­cords for de­vice distribution.
  • Com­plaints and re­turns documentation. 

Re­cords of la­be­l­ing and packaging:

  • La­be­l­ing de­sign and content.
  • Pack­a­ging specifications.
  • In­s­truc­tions for use and safe­ty information.

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Our di­gi­tiza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is a ho­li­stic ECM/DMS sys­tem. The ECM/DMS sys­tem can be con­nec­ted to your exis­ting ERP sys­tem (e.g. SAP) and thus map al­most all do­cu­ment-ba­sed pro­ces­ses in the company.

Live insight into the GxP-compliant document management system of Digital Life Sciences

Why is a Device Master Record (DMR) important? 

  • En­su­ring con­sis­ten­cy: A well-main­tai­ned DMR is cru­cial to en­su­re that every de­vice ma­nu­fac­tu­red is con­sis­tent in de­sign, qua­li­ty and per­for­mance. This con­sis­ten­cy is cru­cial in or­der to meet cus­to­mer ex­pec­ta­ti­ons and re­gu­la­to­ry requirements. 
  • Re­gu­la­to­ry com­pli­ance: Re­gu­la­to­ry aut­ho­ri­ties such as the FDA in the United Sta­tes re­qui­re me­di­cal de­vice ma­nu­fac­tu­r­ers to main­tain a DMR. Com­pli­ance with the­se re­gu­la­ti­ons is non-nego­tia­ble, and a ro­bust DMR is key to mee­ting the­se requirements. 
  • Tracea­bi­li­ty and re­spon­si­bi­li­ty: In the event of pro­duct pro­blems or re­calls, a DMR en­ables ma­nu­fac­tu­r­ers to trace the cau­se of the pro­blem. This tracea­bi­li­ty is cru­cial for ac­coun­ta­bi­li­ty and con­ti­nuous improvement. 
  • Ef­fi­ci­en­cy and cost re­duc­tion: Ef­fi­ci­ent ma­nu­fac­tu­ring pro­ces­ses lead to cost sa­vings. A well-or­ga­ni­zed DMR op­ti­mi­zes pro­duc­tion, re­du­ces er­rors and mi­ni­mi­zes was­te, which ul­ti­m­ate­ly leads to cost savings.

How do I create a DMR?

Do­cu­ment control:

  • Im­ple­ment qua­li­ta­ti­ve Do­cu­ment Con­trol to ef­fi­ci­ent­ly ma­na­ge DMR components.
  • En­su­re that all ch­an­ges to the DMR are do­cu­men­ted, re­view­ed and approved.

Ver­si­on control:

  • Main­tain ver­si­on con­trol to pre­vent the use of out­da­ted do­cu­ments or procedures.
  • Ar­chi­ve ol­der ver­si­ons for reference.

Col­la­bo­ra­ti­on in in­ter­di­sci­pli­na­ry teams:

  • In­vol­ve cross-func­tion­al teams in the crea­ti­on and main­ten­an­ce of the DMR, in­clu­ding de­sign, pro­duc­tion and qua­li­ty control.

Re­gu­lar audits:

  • Per­form re­gu­lar in­ter­nal au­dits to ve­ri­fy the ac­cu­ra­cy and com­ple­ten­ess of the DMR.
  • Edit de­via­ti­ons immediately.

Conclusion

In the me­di­cal de­vice ma­nu­fac­tu­ring sec­tion, the tech­ni­cal pro­duct re­cord (DMR) is the cor­ner­stone of qua­li­ty, con­sis­ten­cy and re­gu­la­to­ry com­pli­ance. By me­ti­cu­lous­ly do­cu­men­ting every aspect of de­vice de­sign, pro­duc­tion and qua­li­ty con­trol, ma­nu­fac­tu­r­ers can en­su­re the safe­ty and ef­fec­ti­ve­ness of their products.

Re­mem­ber, a well-main­tai­ned DMR not only plea­ses re­gu­la­tors, but also con­tri­bu­tes to the suc­cess and re­pu­ta­ti­on of your or­ga­niza­ti­on. So ac­cept the DMR as your ally in de­ploy­ing world-class me­di­cal de­vices to the world.

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Frequently Asked Questions (FAQs)

Is a De­vice Mas­ter Re­cord (DMR) man­da­to­ry for all me­di­cal de­vices?
Yes, a DMR is a re­gu­la­to­ry re­qui­re­ment for all me­di­cal de­vices to en­su­re their qua­li­ty and safety.

How of­ten should a DMR be up­dated?
DMRs should be up­dated when the­re are ch­an­ges to de­vice spe­ci­fi­ca­ti­ons, ma­nu­fac­tu­ring pro­ces­ses or qua­li­ty con­trol procedures.

Can a DMR be in elec­tro­nic for­mat or is a phy­si­cal re­cor­ding re­qui­red?
DMRs can be in elec­tro­nic for­mat as long as they meet the re­gu­la­to­ry re­qui­re­ments for data se­cu­ri­ty and integrity.

What hap­pens if a com­pa­ny fails to main­tain a DMR?
Fail­ure to main­tain a DMR can re­sult in re­gu­la­to­ry non-con­for­mi­ty, pro­duct re­calls and le­gal consequences.

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